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Ostomy bag
EUDAMEDClass I (EU MDR)
Ref OB01L01Model OB01L01, OB01L02, OB02L01, OB02L02, OB03L01, OB03L02, OB09L01
Identity
- Device Name
- Ostomy bag EUDAMED
- Model / Reference
- OB01L01, OB01L02, OB02L01, OB02L02, OB03L01, OB03L02, OB09L01 EUDAMEDOB01L01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800672386 EUDAMED
- Basic UDI-DI
- 697680067OstomybagPJ 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
- Austria 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 Sinopharm Fortune International Trading Corp. — 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 | 697680067OstomybagPJ | Class I | Active |
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Manufacturer
- Manufacturer
- Sinopharm Fortune International Trading Corp.
- EUDAMED SRN
- CN-MF-000038309
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e65a7292-b39f-486b-9893-b7a42a20d07a 61 fields · synced Jun 19, 2026