Identity
- Trade Name
- Fentanyl II Enzyme Immunoassay EUDAMED
- Device Name
- Fentanyl II Enzyme Immunoassay EUDAMED
- Model / Reference
- 10427531190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850624008643 EUDAMED
- Basic UDI-DI
- 0850624008EIAFEN202MD EUDAMED
- Direct Marketing DI
- 00850624008643 EUDAMED
- EMDN Code
- W0102090113 OPIATES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Fentanyl II Enzyme Immunoassay by Lin-Zhi International, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850624008EIAFEN202MD | Class B | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
- EUDAMED SRN
- US-MF-000003373
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 1abfe463-0920-459c-b4b2-936b4c536adc 61 fields · synced Jun 9, 2026