Identity
- Trade Name
- TWO PIECES COLOSTOMY BAG EUDAMED
- Device Name
- ostomy bag EUDAMED
- Model / Reference
- 2041757 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16937359417573 EUDAMED
- Basic UDI-DI
- 693735942041757VJ EUDAMED
- Direct Marketing DI
- 16937359417573 EUDAMED
- EMDN Code
- A10020202 COLOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Two Pieces Colostomy 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 | 693735942041757VJ | 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 ac6d0080-18bb-4d83-9e83-0ec611223691 61 fields · synced Aug 1, 2026