Identity
- Trade Name
- MAGLUMI f-PSA (CLIA) EUDAMED
- Device Name
- f-PSA (CLIA) EUDAMED
- Model / Reference
- 130201005M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145501044 EUDAMED
- Basic UDI-DI
- B-06947145501044 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
No
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
MAGLUMI f-PSA (CLIA) by Shenzhen New Industries Biomedical Engineering 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-06947145501044 | Class IVD Annex II List B | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005655
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2868c5e8-f1f1-4016-af66-d087dbe550da 61 fields · synced Jun 18, 2026