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SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref CG-0003-20Ref CG-0003-01
Identity
- Trade Name
- SARS-CoV-2 Antigen Detection Kit (Colloidal Gold) EUDAMED
- Device Name
- SARS-CoV-2 Antigen Detection Kit (Colloidal Gold) EUDAMED
- Model / Reference
- CG-0003-20 EUDAMEDCG-0003-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229657 EUDAMED06971042229640 EUDAMED
- Basic UDI-DI
- B-06971042229657 EUDAMEDB-06971042229640 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold) by Shanghai Zj Bio-Tech 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-06971042229657 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 3b093d53-c57b-477b-a868-78a6c64a2c04 61 fields · synced Jul 15, 2026
- EUDAMED 3dfd271e-e031-4168-aec8-7f9c95a5ee6c 61 fields · synced May 18, 2026