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Squamous Cell Carcinoma Antigen test (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref HGCL73Model Please see the IFU
Identity
- Trade Name
- Squamous Cell Carcinoma Antigen test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Squamous Cell Carcinoma Antigen test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL73 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700408928 EUDAMED
- Basic UDI-DI
- 697029753457M3 EUDAMED
- EMDN Code
- W0102030116 SQUAMOUS CELL CARCINOMA ANTIGEN EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Squamous Cell Carcinoma Antigen test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697029753457M3 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED b24c4f96-326f-4a61-a680-f931b70d732d 61 fields · synced Jul 21, 2026