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Uralyt-U® pH 5.6-8.0
EUDAMEDClass C (EU MDR)
Ref 90125.8Model Uralyt-U® pH 5.6-8.0
Identity
- Trade Name
- Uralyt-U® pH 5.6-8.0 EUDAMED
- Device Name
- Uralyt-U® pH 5.6-8.0 EUDAMED
- Model / Reference
- Uralyt-U® pH 5.6-8.0 EUDAMED90125.8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681163562 EUDAMED
- Basic UDI-DI
- 4046681151064W7 EUDAMED
- EMDN Code
- W0101060299 URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class C 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Uralyt-U® pH 5.6-8.0 by MACHEREY-NAGEL GmbH & Co. KG — 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 | 4046681151064W7 | Class C | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (1)
- EUDAMED 4c560e11-aa33-427f-8b15-4a291a831434 61 fields · synced Jun 19, 2026