Identity
- Device Name
- Ostomy bags EUDAMED
- Model / Reference
- 3012602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931077302527 EUDAMED
- Basic UDI-DI
- 69310773OSTOMY-BAGSL4 EUDAMED
- Direct Marketing DI
- 06931077302527 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
- Germany 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 bags by Tongxiang BAO-Health Medical Instrument 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 | 69310773OSTOMY-BAGSL4 | Class I | Active |
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Manufacturer
- Manufacturer
- Tongxiang BAO-Health Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012347
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 0025a9bd-b37d-41f6-a4d6-6d534daa85da 61 fields · synced Oct 7, 2026