← Back to catalogue
Carfentanyl Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref CFYL-U11 CFYL-U23Model CFYL-U11, CFYL-U23
Identity
- Trade Name
- Carfentanyl Rapid Test EUDAMED
- Device Name
- Carfentanyl Rapid Test EUDAMED
- Model / Reference
- CFYL-U11, CFYL-U23 EUDAMEDCFYL-U11 CFYL-U23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804817619 EUDAMED
- Basic UDI-DI
- B-06952804817619 EUDAMED
- EMDN Code
- W0102090113 OPIATES 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
Carfentanyl 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-06952804817619 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 58178ef5-fb84-4596-b81e-e0d94701d973 61 fields · synced Jun 17, 2026