Identity
- Trade Name
- ONE PIECE UROSTOMY BAG EUDAMED
- Device Name
- ONE PIECE UROSTOMY BAG EUDAMEDONE PIECE COLOSTOMY BAG EUDAMED
- Model / Reference
- 111045 EUDAMED115038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16937359410451 EUDAMED16937359411380 EUDAMED
- Basic UDI-DI
- 69373594111045ZU EUDAMED693735941150382W EUDAMED
- Direct Marketing DI
- 16937359410451 EUDAMED16937359411380 EUDAMED
- EMDN Code
- A1001030102 ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER EUDAMEDA1001030202 ONE-PIECE UROSTOMY 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 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 | 69373594111045ZU | 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 828dd88f-9e69-4bdd-b5de-b072aef76422 61 fields · synced Jul 31, 2026
- EUDAMED 29b55ad5-ada5-4e29-826c-4964df6b536c 61 fields · synced May 18, 2026