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Total Prostate Specific Antigen (eCLIA)
EUDAMEDClass C (EU MDR)
Ref 0320501104Model 50T, 2×50T, 100T, 2×100T
Identity
- Trade Name
- Total Prostate Specific Antigen (eCLIA) EUDAMED
- Device Name
- Total Prostate Specific Antigen (eCLIA) EUDAMED
- Model / Reference
- 50T, 2×50T, 100T, 2×100T EUDAMED0320501104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685508 EUDAMED
- Basic UDI-DI
- 69703416803205053JG 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 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69703416803205053JG | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b0dbffdf-2251-4eb6-830a-f81d23d2f2b1 61 fields · synced Jun 18, 2026