Identity
- Trade Name
- Ostomy bag EUDAMED
- Device Name
- Ostomy bag EUDAMED
- Model / Reference
- N1S501 EUDAMEDN1S801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926822100039 EUDAMED
- Basic UDI-DI
- 69268221OstomybagBP 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
- France 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 Shandong Chenxing Medical Technology 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 | 69268221OstomybagBP | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Chenxing Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000052699
- Authorised Representative
- AION CIRCUITS, LDA PT-AR-000044689
Sources (1)
- EUDAMED 95d12681-ec28-4603-a7dc-23d594aebbd5 61 fields · synced Jun 18, 2026