Certificate of Conformity ENT Instruments and accessories (replaces issue of )
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- Valentine Stevenson
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1 Gynaecological Diagnostic Instruments (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Amnioscope Tube 12 - H *12 Amnioscope Tube 16 - H *16 Amnioscope Tube 20 - H *20 Amnioscope Illumination Head with bulb - H Amnioscope Illumination Head with F.O H Illumination Head for Small Vaginal Speculum. G-0* Small Vaginal Speculum - G
2 NT 200 Charger and Adaptors (replaces issue of ) We certify that the following product conforms to the specifications of the Medical Device Directive 93/42 EEC and is registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Charger NT 200 NT 200 X
3 Dermatological Diagnostic Instruments (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Dermatoscopes DELTA 10 K-00*.34.00* DELTA 20 K mini 2000 D mini 3000 D * alpha+ D-00*.84.1** Photo Adaptor for DELTA 20 K * Video-Dermatoscope K * Special Camera Dermaphot K Optics Body Dermaphot K ** Adaptor cord SLR Photo Adaptor X K *......
4 ENT Instruments and accessories (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in class I according to annex IX. Conformity is assured according to the guidelines set out in annex VII. Otoscopes BETA 100 B-00*.11.52* BETA 200 B-00* K 100 B-00*.11.57* K 180 B-00* alpha+ D-00* mini 2000 D mini 3000 D ** mini 2000 F.O. D mini 3000 F.O. D ** Operating Otoscope - B-00* Reusable Tips SANALON S black B SANALON S blue B Nasal Specula SANALON S B Disposable Tips All-Spec B * Reusable Specula SANALON S B Disposable Specula UniSpec B * Straight Laryngeal Mirror - B-00*.12.10* Straight Laryngeal Mirror mini 2000/3000 D * Curved Laryngeal Mirror - B-00*.12.20* Tongue Depressor - B-00*.12.30* Tongue Depressor alpha+/mini 2000 D-00* Tongue Depressor mini 3000 D Fiberoptics Nasal Illuminator - B-00*.12.32* Fiberoptics Nasal Illuminator mini 2000 D Fiberoptics Nasal Illuminator mini 3000 D Cliplamp mini 1000 D Cliplamp Head mini 2000 D Cliplamp Head mini 3000 D mini-c Cliplamp Head mini-c D mini-c Cliplamp mini-c Cliplamp D mini-c Cliplamp and Ear Light - D /5 Cliplamp ClipLight D Cliplamp mini 2000 D Cliplamp mini 3000 D Combilamp mini 2000 D Combilamp mini 3000 D Combilamp without handle mini 3000 D Disposable Tongue Blades - B Insufflation Bulb - B Insufflation Bulb - D Spreadable Nasal Speculum - B Universal Speculum - B Geschäftsführer: Dipl. Kfm. Helmut M. Heine, Oliver Heine (BA) WEEE Reg. Nr.: DE
5 Page 2 Certificate of Conformity ENT Instruments and accessories Tip-adapter - B Tip-dispenser All-Spec B Specula-dispenser UniSpec B Geschäftsführer: Dipl. Kfm. Helmut M. Heine, Oliver Heine (BA) WEEE Reg. Nr.: DE
6 F.O. Laryngoscopes and Handles (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42 EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Laryngoscope blades with fiber optics illumination Macintosh F * Macintosh 3m F Heine Paed F * Miller F * Wis F * SANALON F ** FT Flexible Tip F ** Modular FO-Laryng. F ** XP Mac Disposable F * XP Miller Disposable F * Small F.O. laryngoscope battery handle F Small F.O. rechargeable laryngoscope handle F-00* F.O. laryngoscope battery handle F.O. SP F Short F.O. laryngoscope battery handle F.O. F Standard F.O. laryngoscope battery handle battery handle F.O. F Rechargeable handle F.O. NiMH F Rechargeable handle F.O. L Li-ion F Rechargeable handle F.O. L LED F Angled F.O. laryngoscope handle F.O. 2,5 V F F.O. 3,5 V (NiMH) F F.O. 3,5 V (Li-ion) F Rechargeable handle F.O. Li-ion L F BETA F.O. laryngoscope handle BETA F.O. F BETA F.O. R F * / F BETA F.O. TR F * / F BETA F.O. NT F / F Bulb holder F-00* XP handle XP handle F * Short BETA F.O. laryngoscope handle (K3Z) NT2 for NT200 F Herrsching,
7 Handles and Bulbs (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC. They are classified as accessory to medical devices class I (classification according to appendix IX).Conformity is assured according to the guidelines set out in appendix VII in conjunction with the medical device. Battery handle mini 2000 D Battery handle mini 3000 D * Battery handle alpha+ D Rechargeable handle alpha+ D Compact handle - X Compact rechargeable handle - X-00* Battery handle BETA X Cord handle BETA X Rechargeable handle BETA NT 3,5 V X-00* Rechargeable handle BETA R 3,5 V X Rechargeable handle BETA TR 3,5 V X Rechargeable handle / bottom insert BETA L X / X Large battery handle - X Lamp handle - X * Bulbs XHL X-00*.88.*** mini-c handle - D * Herrsching, Geschäftsführer: Dipl. Kfm. Helmut M. Heine, Oliver Heine (BA) WEEE Reg.Nr.: DE
8 Light Sources and Accessories (replaces issue ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Fiber optics projector HK 4000 Y Fiber optics projector HK 6000 Y Fiber optics projector HK 7000 Y Fiber optics projector HK 7000 D Y Fiber optics projector Xenon 1000 Y Xenon 1000 bulb Y Fiber Optics Cable - Y F.O. Adaptors - Y ** Wheeled Floor Stand - Y * Entwicklungsleiter Leitung Qualitätswesen
9 Lights (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in Class I according to appendix IX: Conformity is assured according to the guidelines set out in appendix VII. Head Light SL 350 J Head Light MD 500 F.O. J * Head Light MD 1000 F.O. J * Focusing Video-Prism Optics MD 500/1000 F.O. J Focusing Video-Prism Optics 3S LED Headlight J Clip Lite UBL 100 J Examination Light HL 1200 J * Examination Light HL 5000 J * Universal Fiber Optics Examination Light HKL J * 3S LED-HeadLight 3S LED HeadLight J ** 3S LED-HeadLight UNPLUGGED with mpack UNPLUGGED J S LED-HeadLight UNPLUGGED with EN50/mPack UNPLUGGED J
10 Ophthalmic Instruments and accessories (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Retinoscope BETA 200 C-00*.15.3*3 alpha+ D-00*.83.50* Retinometer Lambda 100 C-00* Handlamp Focalux C-00* Focalux mini 2000 D Focalux mini 3000 D alpha+ Focalux C-00* Ophthalmic examination lamp - C-00* alpha+ D-00* Hand-held Slitlamp HSL 100 C-00* Hand-held Slitlamp HSL 150 C-00* Loupe attachment HSL 10x C-00*.14.60* Hand-held Slitlamp HSL 100 alpha+ D-00* Hand-held Slitlamp HSL 150 alpha+ D-00* Diascleral transilluminator - C-00* Finoff transilluminator - C-00* alpha+ C-00* Illuminated magnifier - C-00* alpha+ D-00* Loupe 5x, 8x C * Threshold tonometer Glaucotest C-00* Binocular loupes / Binocular loupes with i-view (for S-Frame and headband) G, K, HR, HRP, HR-C C *** Binocular loupes C 2.3 K C * Binocular loupe C 2.3/340 C Binocular loupe C 2.3/450 C F.O. LoupeLight F.O. LoupeLight C LED LoupeLight LED LoupeLight C /541 C /238 Illumination attachment - C *29 Depressor - C * Klemme/Universal Clip - C Ophthalmoscopy lenses - C ** Combi-Frames/Frames F, FG, P, S C ** S-Frame for Binocular loupes C /300 for Sigma 150 C S-Guard for Professional L J for Lightweight C for 3S LED Headlight J for MD 1000 J Retrofitting i-view LoupeBracket for 3SLED Headlight J * Retrofitting i-view LoupeBracket for MD 1000 J * Conversion set i-view LoupeBracket 3S LED / MD 1000 J *80 i-view Loupe Bracket J Herrsching,
11 Ophthalmoscopes (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Direct Ophthalmoscopes BETA 200 Professional C-00*.30.10* BETA 200 S C-00* Autofoc C-00*.23.00* K 180 C-00*.30.20* alpha+ Bl. 1 D-00* alpha+ Bl. 2 D-00* alpha+ Bl. 3 D-00* mini 2000 D mini 3000 D ** Indirect Ophthalmoscopes OMEGA 100 C-00* OMEGA 180 C-00* OMEGA 200 C-00* OMEGA 500 C-00* SIGMA 100 C * SIGMA 150, 150 M2 C ** SIGMA 150 KC C Video OMEGA 2C C * Handheld Indirect Ophthalmoscope - C-00*.33.00* Geschäftsführer: Dipl.-Phys. Helmut Heine, Dipl. Kfm. Helmut M. Heine, Oliver Heine (BA)
12 Power Supplies and Chargers (Replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC. They are classified as accessory to medical devices class I (classification according to appendix IX).Conformity is assured according to the guidelines set out in appendix VII in conjunction with the medical device. Wall transformer EN 80 X Wall transformer, basic unit EN 90 X Wall transformer, extension unit EN 90 X Table-top transformer EN 20-1 X Wall transformer EN 100 X Extension unit EN 100 X Single-unit EN X Wall transformer EN 30 X Plug-in transformer E 7 X Plug-in transformer E 8 X Table-top transformer E 9 X Charger NT200 X * Charger NT300 X Charger minint X Rechargeable handle BETA R 3,5 V X Rechargeable handle with transformer BETA TR 3,5 V X Plug-in transformer with control unit EN 15 X Portable power supply Accubox II/Accubox II-L X /645 Plug-in transformer E 10 X Plug-in transformer for 3S LED-Headlight X Extension cord - X (SA) Wall/Table transformer base unit/with mpack/with control unit EN 50 X * Control unit for EN 50 X Transformer with headband rheostat HC 50 X Power supply mpack with Li-ion battery mpack X * mpack LL X * HC-Converter HC-Converter X EN 50 UNPLUGGED X mpack UNPLUGGED X Herrsching,
13 Proctological instruments and accessories (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42 EEC and are registered in Class I according to appendix IX. Conformity is assured according to the guidelines set out in appendix VII. Anoscope/Proctoscope with distal annular illumination E *** E *13 Swivel lens E Anoscope with annular fiber optics illumination - E ** Instrument head for Unispec tubes E Unispec tubes - E ** E ** E ** Anoscope/Proctoscope with proximal illumination - E-00*.19.1** Telescope - E Biopsy forceps - E * Sponge holder - E Suction tube - E Insufflation bulb - E Anal spreadable speculum - E Illumination attachment - E-00* Herrsching,
14 Rechargeable batteries (Replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC. They are classified as accessory to medical devices class I (classification according to appendix IX).Conformity is assured according to the guidelines set out in appendix VII in conjunction with the medical device. Rechargeable battery M2Z D Rechargeable battery S2Z X Rechargeable battery NT 2,5 V X Rechargeable battery S3Z X Rechargeable battery 3,5 V NiMH X Rechargeable battery M3Z X Rechargeable battery S5Z X Rechargeable battery HC 6V X Rechargeable battery 3,5 V Li-ion X Rechargeable battery NiMH 6V X Rechargeable battery Li-ion for mpack / mpack LL X Rechargeable battery Li-Pol for mpack UNPLUGGED X Rechargeable battery K3Z NiMH X Rechargeable battery mini 2Z X Rechargeable battery 3,5 V Li-ion L X Herrsching,
15 Sphygmomanometers and Stethoscopes (replaces issue of ) We certify that the following products conform to the specifications of the Medical Device Directive 93/42/EEC and are registered in according to Appendix IX, in Class I M (Sphygmomanometers) and in Class I. Conformity assessment is assured according to the guidelines set out in Annex VII. Additional requirements for a measuring device assured according to Annex V. Aneroid Sphygmomanometers GAMMA ST Cat.-No. M * GAMMA XXL Cat.-No. M * GAMMA XXL LF Cat.-No. M ** GAMMA G5 Cat.-No. M * GAMMA G7 Cat.-No. M * GAMMA GST Cat.-No. M GAMMA GP Cat.-No. M * Cuffs for GAMMA XXL LF- Sphygmomanometers Cuffs for GAMMA GST- Sphygmomanometers Service Case for GAMMA G5, G7, GP Cat.-No. M *** Cat.-No. M Cat.-No. M *** Stethoscopes GAMMA Cat.-No. M * GAMMA C Cat.-No. M Replacement Parts: Cuffs, Rubber Bladders, Pressure Balls Cat.-No. M **......
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