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PGI/ PGII Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref BT21003Ref BT21002
Identity
- Trade Name
- PGI/ PGII Rapid Quantitative Test EUDAMEDPGII Rapid Quantitative Test EUDAMED
- Device Name
- PG Ⅰ/PG Ⅱ Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMEDPG Ⅱ Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT21003 EUDAMEDBT21002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260208685 EUDAMED06933260208678 EUDAMED
- Basic UDI-DI
- B-06933260208685 EUDAMEDB-06933260208678 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/ PGII 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-06933260208685 | 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 (4)
- EUDAMED 87d4d053-cb39-413c-bad1-bae391e12225 61 fields · synced Jul 21, 2026
- EUDAMED 0be64a45-bef6-4672-8bf8-c7ebe927cbc0 61 fields · synced May 19, 2026
- EUDAMED 7f5a3bc8-bf34-438c-8dff-01e6c2516e7c 61 fields · synced Jul 9, 2026
- EUDAMED 702acf42-8df6-4e56-aeef-d205d4a3dd85 61 fields · synced Jul 21, 2026