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G17 Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0505201Ref BT0505204Ref BT0505203Ref BT0505205Ref BT0505202
Identity
- Trade Name
- G17 Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- G17 Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0505201 EUDAMEDBT0505204 EUDAMEDBT0505203 EUDAMEDBT0505205 EUDAMEDBT0505202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260206872 EUDAMED06933260206902 EUDAMED06933260206896 EUDAMED06933260206919 EUDAMED06933260206889 EUDAMED
- Basic UDI-DI
- B-06933260206872 EUDAMEDB-06933260206902 EUDAMEDB-06933260206896 EUDAMEDB-06933260206919 EUDAMEDB-06933260206889 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
G17 Rapid Quantitative Test (Chemiluminescence Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06933260206872 | 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 (10)
- EUDAMED 5de0173e-4aa2-4b94-b4c5-119635b77f56 61 fields · synced Oct 6, 2026
- EUDAMED da363b75-a123-432b-8337-b2592d000797 61 fields · synced May 18, 2026
- EUDAMED ac7fbbf0-3a27-4e2a-ad08-1b54c094039c 61 fields · synced May 18, 2026
- EUDAMED 5e37db2f-a112-41e8-984d-9ca17e57d069 61 fields · synced May 18, 2026
- EUDAMED 96649f5e-98c2-4252-a3b1-f360aa9e00eb 61 fields · synced May 19, 2026
- EUDAMED f01fe362-dc63-4d4c-8242-bfcda6b0db5f 61 fields · synced Jun 18, 2026
- EUDAMED 5fbcbe26-8205-4126-ab31-ba94574538b9 61 fields · synced Jul 11, 2026
- EUDAMED 4f64c25f-1e16-47bd-8647-6509965364dc 61 fields · synced Jul 15, 2026
- EUDAMED f184e860-4c02-4270-a6d3-f3265317353c 61 fields · synced Aug 2, 2026
- EUDAMED f9585f3a-66e6-4b18-a71f-bcdb38265765 61 fields · synced Aug 3, 2026