Identity
- Device Name
- Strep B Test EUDAMED
- Model / Reference
- R66-112 EUDAMEDR66-110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571866012 EUDAMED06941571866005 EUDAMED
- Basic UDI-DI
- B-06941571866012 EUDAMEDB-06941571866005 EUDAMED
- EMDN Code
- W0105090104 STREP. B - RT & POC 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
Strep B 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-06941571866012 | 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 68804d3a-1cd3-4b3e-8acd-4ab426c657e3 61 fields · synced Oct 6, 2026
- EUDAMED fb6c2427-ee1e-4d7f-bcca-4f3b6fefad12 61 fields · synced May 18, 2026