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AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0503701Ref BT0503703Ref BT0503702
Identity
- Trade Name
- AMH Rapid Quantitative Test(Chemiluminescence Immunoassay) EUDAMED
- Device Name
- AMH Rapid Quantitative Test(Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0503701 EUDAMEDBT0503703 EUDAMEDBT0503702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260205899 EUDAMED06933260205912 EUDAMED06933260205905 EUDAMED
- Basic UDI-DI
- B-06933260205899 EUDAMEDB-06933260205912 EUDAMEDB-06933260205905 EUDAMED
- EMDN Code
- W0102160999 INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - 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
AMH Rapid Quantitative Test(Chemiluminescence Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06933260205899 | 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 (6)
- EUDAMED dba7aa16-ee27-46f3-b8ff-3b3eb26e6f66 61 fields · synced Oct 6, 2026
- EUDAMED 7fd94b36-cca1-43ea-b5c0-ced2726cf37a 61 fields · synced May 18, 2026
- EUDAMED d5b08c07-c24a-4739-9468-18077e5a93db 61 fields · synced May 18, 2026
- EUDAMED 676b2e3b-9f99-4aae-a7e2-7f2fb6906a1b 61 fields · synced Jul 12, 2026
- EUDAMED c289b4b7-89f6-4d79-952e-a1870b6771b0 61 fields · synced Jul 24, 2026
- EUDAMED 578b7db4-f694-48e0-9972-953831b8109f 61 fields · synced Jul 31, 2026