Identity
- Trade Name
- PGI Rapid Quantitative Test EUDAMED
- Device Name
- PG Ⅰ Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT21001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260208661 EUDAMED
- Basic UDI-DI
- B-06933260208661 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
PGI Rapid Quantitative Test by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Preferentially expressed antigen in melanoma (PRAME) IVD, antibody.
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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-06933260208661 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED a6591c31-e673-450b-915b-67bd97097d18 61 fields · synced Jun 19, 2026
- EUDAMED 6c6b7082-8db5-47f2-9166-3bc732652001 61 fields · synced Jun 19, 2026