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Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)
EUDAMEDClass IVD General (EU MDR)
Ref GCCD(GDH)-602a
Identity
- Trade Name
- Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) EUDAMED
- Device Name
- Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) EUDAMED
- Model / Reference
- GCCD(GDH)-602a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCCD(GDH)-602aH3 EUDAMED
- Basic UDI-DI
- B-GCCD(GDH)-602aH3 EUDAMED
- EMDN Code
- W0105011801 C.DIFFICILE GDH DETECTION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) by Zhejiang Orient Gene 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-GCCD(GDH)-602aH3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 66743dd2-985c-4a2f-8f2a-8f1376206804 61 fields · synced Oct 6, 2026