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Roche Combur-10 UX StripReader
EUDAMEDClass A (EU MDR)
Ref C10R
by TestCard Ltd
Identity
- Device Name
- Roche Combur-10 UX StripReader EUDAMED
- Model / Reference
- C10R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50606975730000 EUDAMED
- Basic UDI-DI
- 506069757C10R7A EUDAMED
- Direct Marketing DI
- 50606975730000 EUDAMED
- EMDN Code
- W020101020101 URINE STRIP READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Roche Combur-10 UX StripReader by TestCard Ltd — Class A — 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 | 506069757C10R7A | Class A | Active |
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Manufacturer
- Manufacturer
- TestCard Ltd
- EUDAMED SRN
- GB-MF-000013002
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED fe213886-099f-4b37-8bb8-2de441293a29 61 fields · synced Jun 19, 2026