Identity
- Trade Name
- One system urostomy bag EUDAMED
- Device Name
- One system urostomy bag EUDAMED
- Model / Reference
- 111245 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16937359411830 EUDAMED
- Basic UDI-DI
- 6937359411124529 EUDAMED
- Direct Marketing DI
- 16937359411830 EUDAMED
- EMDN Code
- A1001030101 ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
One system urostomy bag by Wuhan Sitaili Medical Apparatus Development Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6937359411124529 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Sitaili Medical Apparatus Development Co., Ltd
- EUDAMED SRN
- CN-MF-000010103
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 2be25b68-1476-40f7-b637-6f051eda6e14 61 fields · synced Jul 19, 2026