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URYXXON® Control Strip
EUDAMEDClass A (EU MDR)
Ref 930988Model URYXXON® Control Strip
Identity
- Trade Name
- URYXXON® Control Strip EUDAMED
- Device Name
- URYXXON® Control Strip EUDAMED
- Model / Reference
- URYXXON® Control Strip EUDAMED930988 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681141683 EUDAMED
- Basic UDI-DI
- 4046681151897XW EUDAMED
- EMDN Code
- W010106020602 URINE TESTING CALIBRATORS AND STANDARDS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
URYXXON® Control Strip by MACHEREY-NAGEL GmbH & Co. KG — 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 | 4046681151897XW | Class A | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (1)
- EUDAMED ba44a565-66cc-4e62-9e2d-cd4a0d61deb3 61 fields · synced Oct 6, 2026