Identity
- Trade Name
- STREPTEX DISPOSABLE REACTION CARDS EUDAMED
- Device Name
- STREPTEX DISPOSABLE REACTION CARDS EUDAMED
- Model / Reference
- R30368601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056080501550 EUDAMED
- Basic UDI-DI
- 50560805StreptexCardM4 EUDAMED
- EMDN Code
- W0105011199 STREPTOCOCCAL REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Streptex Disposable Reaction Cards by Remel Europe Ltd — Class C — 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 | 50560805StreptexCardM4 | Class C | Active |
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Manufacturer
- Manufacturer
- Remel Europe Ltd
- EUDAMED SRN
- GB-MF-000016733
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 608ab167-665c-4025-be84-c598331b9350 61 fields · synced Jun 18, 2026