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Caffeine Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref CAF-U11 CAF-U23Model CAF-U11, CAF-U23
Identity
- Trade Name
- Caffeine Rapid Test EUDAMED
- Device Name
- Caffeine Rapid Test EUDAMED
- Model / Reference
- CAF-U11, CAF-U23 EUDAMEDCAF-U11 CAF-U23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804816889 EUDAMED
- Basic UDI-DI
- B-06952804816889 EUDAMED
- EMDN Code
- W0102080401 CAFFEINE 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Caffeine Rapid Test by Assure Tech. (hangzhou) 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-06952804816889 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d54be0ec-8fa2-4e2b-8f39-cde6c1305647 61 fields · synced Jul 9, 2026