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PG I Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0505305Ref BT0505302Ref BT0505304
Identity
- Trade Name
- PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0505305 EUDAMEDBT0505302 EUDAMEDBT0505304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260207015 EUDAMED06933260206988 EUDAMED06933260207008 EUDAMED
- Basic UDI-DI
- B-06933260207015 EUDAMEDB-06933260206988 EUDAMEDB-06933260207008 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
PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06933260207015 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED a33ef979-4dea-4902-9cb0-780c175b9323 61 fields · synced Aug 3, 2026
- EUDAMED 1d003a9b-9945-40d9-8dbc-d3176dcea33d 61 fields · synced May 17, 2026
- EUDAMED 36498cd6-d4fb-47ae-b352-ede8a0e23e6b 61 fields · synced May 18, 2026
- EUDAMED 7a9e4715-ada6-4d28-aea9-49536a0d8e37 61 fields · synced Jul 13, 2026
- EUDAMED c170b2cf-637c-45b6-9a82-ad26621ab02f 61 fields · synced Jul 25, 2026
- EUDAMED a8d54c30-eb14-4251-a54a-222b9a30742c 61 fields · synced Aug 3, 2026