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Mycobacterium Tuberculosis Nucleic Acid Assay Control
EUDAMEDClass IVD General (EU MDR)
Ref CRM1010602-1
Identity
- Device Name
- Mycobacterium Tuberculosis Nucleic Acid Assay Control EUDAMED
- Model / Reference
- CRM1010602-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975327120479 EUDAMED
- Basic UDI-DI
- B-06975327120479 EUDAMED
- EMDN Code
- W0105094001 CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Mycobacterium Tuberculosis Nucleic Acid Assay Control by Guangzhou Pluslife Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975327120479 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Pluslife Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000025784
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED dffa9454-a62c-40a8-bf23-7a9950385fcc 61 fields · synced Jul 30, 2026