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CYDXStrips Urine 2GK
EUDAMEDClass B (EU MDR)
Ref Urine-2GKModel Urine-10 - Urine-2GK - Urine-2GP - Urine-3
Identity
- Trade Name
- CYDXStrips Urine 2GK EUDAMED
- Device Name
- CYDXStrips EUDAMED
- Model / Reference
- Urine-10 - Urine-2GK - Urine-2GP - Urine-3 EUDAMEDUrine-2GK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100615 EUDAMED
- Basic UDI-DI
- 54040351CYDXStripsWH EUDAMED
- Direct Marketing DI
- 05404035100615 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
CYDXStrips Urine 2GK by Cypress Diagnostics — Class B — 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 | 54040351CYDXStripsWH | Class B | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED 2cbfa7d9-658a-4612-a79d-ecff0f974944 61 fields · synced Jun 19, 2026