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Medi-Test Combi 11
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref 930871Model Medi-Test URYXXON® Stick 10Ref 93060.005Ref 93060.004
Identity
- Trade Name
- Medi-Test Combi 11 EUDAMED
- Device Name
- Medi-Test URYXXON® Stick 10 EUDAMED
- Model / Reference
- Medi-Test URYXXON® Stick 10 EUDAMED930871 EUDAMED93060.005 EUDAMED93060.004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681000805 EUDAMED04046681165252 EUDAMED04046681165276 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 EUDAMEDSlovakia EUDAMEDSweden 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
Medi-Test Combi 11 by MACHEREY-NAGEL GmbH & Co. KG — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991927 | Class B | Active |
| 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 (4)
- EUDAMED eabeb068-8ee5-4abd-a183-418d3ba4e2c8 61 fields · synced Jul 26, 2026
- EUDAMED 9c64f9f1-af4e-42cc-b4b2-53bbef4246ea 61 fields · synced May 17, 2026
- EUDAMED 966d5c17-42e6-4cae-8f62-9f2716812308 61 fields · synced May 18, 2026
- FDA 510(k) K991927 1 fields · synced May 18, 2026