Identity
- Trade Name
- URYXXON® 500 EUDAMED
- Device Name
- URYXXON® 500 EUDAMED
- Model / Reference
- URYXXON® 500 EUDAMED930080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681090721 EUDAMED
- Basic UDI-DI
- 4046681151866XK EUDAMED
- EMDN Code
- W020101020101 URINE STRIP READERS 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Uryxxon® 500 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 | 4046681151866XK | Class A | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (1)
- EUDAMED 186af0bb-0fdb-44d4-a4c9-61742f169fb8 61 fields · synced Jun 19, 2026