Identity
- Device Name
- Ostomy Bag EUDAMED
- Model / Reference
- one-piece EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977206050501 EUDAMED
- Basic UDI-DI
- 697720605OstomyPS EUDAMED
- EMDN Code
- A1001010101 ONE-PIECE COLOSTOMY 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
Ostomy Bag by Ningbo Foyomed Medical Instruments 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 | 697720605OstomyPS | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Foyomed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032266
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 13140678-3279-497e-8ae0-dadea8154a75 61 fields · synced Jun 19, 2026