Identity
- Trade Name
- URIT S11 Sheath for Urine Analysis EUDAMED
- Device Name
- Sheath for Urine Analysis EUDAMED
- Model / Reference
- URIT S11 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740723268 EUDAMED
- Basic UDI-DI
- 69357407IUSS00000127 EUDAMED
- EMDN Code
- W0101060299 URINE TESTING - OTHER 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
URIT S11 Sheath for Urine Analysis by URIT Medical Electronic Co., Ltd. — 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 | 69357407IUSS00000127 | Class A | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 74d8a758-2f2e-4cb0-ad57-201a6bdb43af 61 fields · synced Oct 7, 2026