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Total Prostate Specific Antigen test (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref HGCL24Model Please see the IFU
Identity
- Trade Name
- Total Prostate Specific Antigen test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Total Prostate Specific Antigen test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700404876 EUDAMED
- Basic UDI-DI
- 697029753068LL EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC 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
Total Prostate Specific 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 | 697029753068LL | 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 b5572ef2-d6d9-4bfb-a3a7-51ce9f0b4b50 61 fields · synced Jun 18, 2026