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Nanbase C-96 V4.0
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 4NAE3Ref 4NAE12
Identity
- Trade Name
- NANBASE C-96 V4.0 EUDAMED
- Device Name
- NANBASE C-96 V4.0 EUDAMED
- Model / Reference
- 4NAE3 EUDAMED4NAE12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712803531297 EUDAMED04712803531303 EUDAMED
- Basic UDI-DI
- B-04712803531297 EUDAMEDB-04712803531303 EUDAMED
- EMDN Code
- W0105020303 HCV ANTIBODY (TOTAL) EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Nanbase C-96 V4.0 by General Biologicals Corporation — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-04712803531297 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- General Biologicals Corporation
- EUDAMED SRN
- TW-MF-000024694
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 2de2e7af-4d76-47fc-ba77-e9ac09db7667 61 fields · synced Jul 17, 2026
- EUDAMED 7df8e0a8-3adb-4425-9555-027c742ee407 61 fields · synced May 19, 2026