Identity
- Trade Name
- TWO PIECES COLOSTOMY BASEPLATE EUDAMED
- Device Name
- ostomy baseplate EUDAMED
- Model / Reference
- 3044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16937359430442 EUDAMED
- Basic UDI-DI
- 693735943044LH EUDAMED
- Direct Marketing DI
- 16937359430442 EUDAMED
- EMDN Code
- A1002010101 COLOSTOMY PLATES, WITH NON-RETRACTED STOMA 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 Baseplate 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 | 693735943044LH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 3095ac82-f022-4346-a76c-91dae344984a 61 fields · synced Jun 17, 2026