Identity
- Trade Name
- ONE PIECE COLOSTOMY BAG EUDAMED
- Device Name
- ONE PIECE COLOSTOMY BAG EUDAMEDostomy bag EUDAMED
- Model / Reference
- 101155 EUDAMED105138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16937359411557 EUDAMED16937359410383 EUDAMED
- Basic UDI-DI
- 69373594101155ZR EUDAMED693735941051382Q EUDAMED
- Direct Marketing DI
- 16937359411557 EUDAMED16937359410383 EUDAMED
- EMDN Code
- A1001010102 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER EUDAMEDA1001010202 ONE-PIECE COLOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, 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
One Piece 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 | 69373594101155ZR | 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 (2)
- EUDAMED 51ff2167-3409-4adf-8e41-73f0e11631f1 61 fields · synced Aug 2, 2026
- EUDAMED c24f4ed7-f8ea-471b-b87d-0ff58cf8d7bb 61 fields · synced May 18, 2026