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Malaysia : Announcement on medical device registration certificate number change
Dear valued customers,
Please be informed that the Medical Device Registration Certificate numbers for SKUs below have been added with new license numbers, effective from 30 June 2023:
| No. | Identifier (SKU) | Medical Device Name | Registration number to be printed on label (New License Number) | Old license number） |
|---|---|---|---|---|
| 1. | 491461 | Rovers® Cervex-Brush® | GA5208623-115152 | GMD23893992319A |
| 2. | 271056 | BD BACTEC™ INSTRUMENTED BLOOD CULTURE SYSTEMS | IVDB6379423-138077 | IVDB73294246418 |
| 3. | 340334 | BD Blood Cell Count IVD Kit and Controls | IVDB6943323-121783 | IVDB71229158618 |
| 4. | 442020 | BD BACTEC™ INSTRUMENTED BLOOD CULTURE SYSTEMS | IVDB6379423-138077 | IVDB73294246418 |
| 5. | 442021 | BD BACTEC™ INSTRUMENTED BLOOD CULTURE SYSTEMS | IVDB6379423-138077 | IVDB73294246418 |
| 6. | 442023 | BD BACTEC™ INSTRUMENTED BLOOD CULTURE SYSTEMS | IVDB6379423-138077 | IVDB73294246418 |
| 7. | 442288 | BD BACTEC™ INSTRUMENTED BLOOD CULTURE SYSTEMS | IVDB6379423-138077 | IVDB73294246418 |
| 8. | 647205 | BD BACTEC™ INSTRUMENTED BLOOD CULTURE SYSTEMS | IVDA7769223-132506 | IVDB73294246418 |
Please be informed that the old license numbers are still valid, but only until 13 January 2024.
Should you have any questions or experience any issues associated with the medical device labelling of the SKUs listed above, please contact your local BD representative.
Sincerely,
11-Sep-2023