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Disposable Urine Collector
EUDAMEDClass A (EU MDR)
Ref UC-05Model UC-05,UC-06,UC-07,UC-08,UC-09
Identity
- Device Name
- Disposable Urine Collector EUDAMED
- Model / Reference
- UC-05,UC-06,UC-07,UC-08,UC-09 EUDAMEDUC-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976450346002 EUDAMED
- Basic UDI-DI
- 697645034UC001GY EUDAMED
- EMDN Code
- A06030301,A06030302,A06030399 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Disposable Urine Collector by Wuxi Kaishun Medical Device Manufacturing 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 | 697645034UC001GY | Class A | Active |
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Manufacturer
- Manufacturer
- Wuxi Kaishun Medical Device Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000017125
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1c1db01e-0a07-46c7-a542-1d0be0116487 61 fields · synced Oct 5, 2026