← Back to catalogue
Uritrak - 1, 2, 3, 5 and 10
EUDAMEDClass IVD General (EU MDR)
Ref 1100 100Ref 1100 010Ref 1100 030Ref 1100 020
Identity
- Trade Name
- Uritrak - 1,2,3, 5 and 10 EUDAMED
- Device Name
- Uritrak - 1,2,3, 5 and 10 EUDAMED
- Model / Reference
- 1100 100 EUDAMED1100 010 EUDAMED1100 030 EUDAMED1100 020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041041216 EUDAMED62230041040844 EUDAMED62230041041070 EUDAMED62230041040912 EUDAMED
- Basic UDI-DI
- B-62230041041216 EUDAMEDB-62230041040844 EUDAMEDB-62230041041070 EUDAMEDB-62230041040912 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Uritrak - 1, 2, 3, 5 and 10 by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-62230041041216 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED f2d1a61a-05ec-461d-bdff-16b364f47d1c 61 fields · synced Oct 6, 2026
- EUDAMED b60375ce-1193-4ddb-a853-edf77a66282d 61 fields · synced May 18, 2026
- EUDAMED 64408643-fc13-4ecc-94f8-1ddd8703c578 61 fields · synced May 18, 2026
- EUDAMED 4e3b3559-a586-48e4-b766-28673e21bc68 61 fields · synced May 19, 2026