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Amphetamine （AMP） Rapid Test（Urine）
EUDAMEDClass IVD General (EU MDR)
Ref BT0104601
Identity
- Trade Name
- Amphetamine （AMP） Rapid Test（Urine） EUDAMED
- Device Name
- Amphetamine （AMP） Rapid Test（Urine） EUDAMED
- Model / Reference
- BT0104601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260208135 EUDAMED
- Basic UDI-DI
- B-06933260208135 EUDAMED
- EMDN Code
- W0102160501 AMPHETAMINES - RT & POC 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
Amphetamine （AMP） Rapid Test（Urine） by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06933260208135 | 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 (2)
- EUDAMED 77171b52-9ca4-4684-b8de-d6e4675a1699 61 fields · synced Oct 6, 2026
- EUDAMED c8461df7-5157-4d7d-8662-de4f23e77e01 61 fields · synced Jul 17, 2026