Identity
- Device Name
- Buprenorphine Test EUDAMED
- Model / Reference
- R53-110 EUDAMEDR53-112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571853005 EUDAMED06941571853104 EUDAMED
- Basic UDI-DI
- B-06941571853005 EUDAMEDB-06941571853104 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
Buprenorphine 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-06941571853005 | 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 e5e8c8b2-9e5e-4bcc-aca7-7c606ad40416 61 fields · synced Jul 21, 2026
- EUDAMED 201d42b1-bd10-44e5-8679-31d688e7579e 61 fields · synced May 18, 2026