Certificate of Conformity

Transcription

1 Certificate of Conformity Good Distribution Practice for Devices (GDPMD) This is to certify that: Materials Sdn Bhd A , 12th Floor, Wisma AmFirst Tower 1, Jalan SS7/15, Kelana Jaya Petaling Jaya Selangor, Malaysia Holds Certificate No: FS Scope of certification Local Authorised Representative (LAR), Import, Storage & Handling, warehousing, Distribution (including transportation), Installation, Testing & Commissioning, Maintenance, Calibration and Documentation (including traceability) of hematology analyser, hematology reagents, histology reagent (stains, dyes, fixative & cleaning agent) and medical s listed in Annex 1. [Outsourced installation, testing & commissioning, maintenance, calibration to Raxxon Diagnostic Sdn. Bhd.] For and on behalf of BSI Evelyn Chye, General Manager Originally registered: 23/06/2015 Latest Revision Date: 23/06/2015 Effective Date: 23/06/2015 Expiry Date: 22/06/2018 Page 1 of 2 CAB Registration No : MDA/CAB-005

2 Certificate No: FS Location Materials Sdn Bhd A , 12th Floor, Wisma AmFirst Tower 1, Jalan SS7/15, Kelana Jaya Petaling Jaya Selangor, Malaysia Registered Activities Local Authorised Representative (LAR), Import, Storage & Handling, warehousing, Distribution (including transportation), Installation, Testing & Commissioning, Maintenance, Calibration and Documentation (including traceability) of hematology analyser, hematology reagents, histology reagent (stains, dyes, fixative & cleaning agent) and medical s listed in Annex 1. [Outsourced installation, testing & commissioning, maintenance, calibration to Raxxon Diagnostic Sdn. Bhd.] Materials Sdn Bhd No. 2 Jalan Sunggai Chadong 8 Off Batu 5, Jalan Kapar Klang Selangor, Malaysia Local Authorised Representative (LAR), Import, Storage & Handling, warehousing, Distribution (including transportation), Installation, Testing & Commissioning, Maintenance, Calibration and Documentation (including traceability) of hematology analyser, hematology reagents, histology reagent (stains, dyes, fixative & cleaning agent) and medical s listed in Annex 1. [Outsourced installation, testing & commissioning, maintenance, calibration to Raxxon Diagnostic Sdn. Bhd.] Originally registered: 23/06/2015 Latest Revision Date: 23/06/2015 Effective Date: 23/06/2015 Expiry Date: 22/06/2018 Page 2 of 2

3 Certificate No: FS ANNEX 1 : List of s dealt with by the establishment - No BENESPHERA 3- PART DIFF HEMATOLOGY ANALYZER (H32) CyMet BS3 CN DETECTOTERGE BS HYPOCHLORITE 0.5% HYPOCHLORITE 0.5% 6 DILUID 100 PLUS 7 CYMET KX CN 8 PROCLEAN PLUS 9 DILUID III DIFF 10 CYMET MICRO CN 11 CYMET MICRO 12 PROCLEAN EXTRA / BeneSphera 2983 A PE A In vitro PE A cluster 3917 A A A System A A System A A A PE A 41955

4 / DILUID NR CYMET NR III, CN DETECTOTERGE TM HYPOCHLORITE NR Control, Low Control, Normal Control, High Control, Low Control, Normal Control, High 23 Low Normal High PC System A PE A System A PC A A A A A A A A A A 30533

5 26 Low Normal High 29 Cal Set Benesphera Diluent (3-part Diff) Benesphera CF Lyse (3-part Diff) Benesphera Rinse (3-part Diff) Benesphera EZ Cleaner (3-part Diff) Benesphera Probe Cleaner (3-part Diff) 35 EOSIN-Y Alcoholic 36 EOSIN-Y Alcoholic FORMALDEHYDE SOLUTION 10% V/V FORMALDEHYDE SOLUTION 10%V/V / 3421 A A A Single A BeneSphera A BeneSphera A BeneSphera System A BeneSphera A BeneSphera A PE A PE A PC A A 33489

6 / 39 CERVIX SPRAY FIXATIVE 40 GIEMSA 41 GIEMSA HEMATOXYLINE (MAYERS) HEMATOXYLINE MODIFIED (HARRIS, GILL II)) HEMATOXYLINE MODIFIED (HARRIS, GILL II)) 45 LEISHMAN 46 WRIGHT 47 MAY-GRUNWALD SOLUTION 2A SOLUTION 2A SOLUTION 2B SOLUTION 2B Single A A A Single A A A Single A Single A Single A PE A PE A PE A PE A 39734

7 / SOLUTION 3B SOLUTION 3B 54 ULTRACLEAR 55 ULTRAKIT 56 ULTRAKIT PE A PE A PE Single A A A 33835