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Free Prostate Specific Antigen Assay kit
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 69543760F000045ZModel 100 Tests
Identity
- Trade Name
- Free Prostate Specific Antigen Assay kit EUDAMED
- Device Name
- Free Prostate Specific Antigen Assay kit EUDAMED
- Model / Reference
- 100 Tests EUDAMED69543760F000045Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954376012362 EUDAMED
- Basic UDI-DI
- B-06954376012362 EUDAMED
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Free Prostate Specific Antigen Assay kit by Beijing Leadman Biochemistry Co., Ltd. — Class IVD Annex II List B — 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-06954376012362 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
- EUDAMED SRN
- CN-MF-000020150
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9a7cb1b0-c4d2-4ef4-a0c8-a1f672729656 61 fields · synced Oct 6, 2026