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Urispec PLUS 3 PLUS
EUDAMEDClass B (EU MDR)
Ref 900-2637Model Medi-Test URYXXON® Stick 10
Identity
- Trade Name
- Urispec PLUS 3 PLUS EUDAMED
- Device Name
- Medi-Test URYXXON® Stick 10 EUDAMED
- Model / Reference
- Medi-Test URYXXON® Stick 10 EUDAMED900-2637 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681164859 EUDAMED
- Basic UDI-DI
- 4046681151040VR EUDAMED
- EMDN Code
- W0101060201 URINE SINGLE TEST STRIPS (INCL. TABLETS) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Urispec PLUS 3 PLUS by MACHEREY-NAGEL GmbH & Co. KG — 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 | 4046681151040VR | Class B | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (1)
- EUDAMED d9e1d634-9fa7-4e7a-9606-6df8dfc8fa4f 61 fields · synced Jun 19, 2026