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Free Prostate Specific Antigen (eCLIA)
EUDAMEDClass C (EU MDR)
Ref 0320501004Model 50T, 2×50T, 100T, 2×100TRef 0320501002Ref 0320501003
Identity
- Trade Name
- Free Prostate Specific Antigen (eCLIA) EUDAMED
- Device Name
- Free Prostate Specific Antigen (eCLIA) EUDAMED
- Model / Reference
- 50T, 2×50T, 100T, 2×100T EUDAMED0320501004 EUDAMED0320501002 EUDAMED0320501003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341685546 EUDAMED06970341685522 EUDAMED06970341685539 EUDAMED
- Basic UDI-DI
- 69703416803205054JJ EUDAMED
- EMDN Code
- W0102030114 FREE 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
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
New Device
No
EUDAMED
Free 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 | 69703416803205054JJ | 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 (3)
- EUDAMED d922bd5b-f713-4aa9-98fa-37002fb0e172 61 fields · synced Jul 23, 2026
- EUDAMED 94a0fc01-9dba-4ed8-90ea-6ca0eb75aba4 61 fields · synced May 17, 2026
- EUDAMED 82bebff9-8cd7-479b-afe4-c12e827e08b8 61 fields · synced May 19, 2026