Identity
- Device Name
- Fentany Test EUDAMED
- Model / Reference
- R74-110 EUDAMEDR74-112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571874000 EUDAMED06941571874109 EUDAMED
- Basic UDI-DI
- B-06941571874000 EUDAMEDB-06941571874109 EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Fentany Test by Ameritech Diagnostic Reagent (Jiaxing) 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-06941571874000 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED fe221bc3-74be-42a2-854c-208ac5a787b3 61 fields · synced Oct 6, 2026
- EUDAMED 3a611bf3-ca1d-422e-b03c-53916608ce05 61 fields · synced May 18, 2026