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PG II Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0505405Ref BT0505401Ref BT0505404
Identity
- Trade Name
- PG II Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- PG II Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0505405 EUDAMEDBT0505401 EUDAMEDBT0505404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260207060 EUDAMED06933260207022 EUDAMED06933260207053 EUDAMED
- Basic UDI-DI
- B-06933260207060 EUDAMEDB-06933260207022 EUDAMEDB-06933260207053 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 II 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-06933260207060 | 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 31478f19-294b-4ecc-b58c-113b74bf9a35 61 fields · synced Oct 6, 2026
- EUDAMED 992a4fac-7c30-45d5-b43b-a307e2cb3981 61 fields · synced May 17, 2026
- EUDAMED d1060095-8b80-46ec-b5ba-acf7484de657 61 fields · synced May 18, 2026
- EUDAMED 4eebc1d9-295d-47e2-ae6c-ead85e3cbb30 61 fields · synced Jul 10, 2026
- EUDAMED 638a1285-df34-4d0b-b427-ec487febe477 61 fields · synced Jul 12, 2026
- EUDAMED 86fba490-abbb-4de1-b95a-2996a81b8041 61 fields · synced Oct 6, 2026