Identity
- Trade Name
- Flexima® EUDAMED
- Device Name
- Flexima-Softima Drain RU Cvx pouches EUDAMED
- Model / Reference
- 42720RO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046961027621 EUDAMED
- Basic UDI-DI
- 403923900000019427 EUDAMED
- Unit of Use DI
- 04046961027614 EUDAMED
- EMDN Code
- A1001020202 ONE-PIECE ILEOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH 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
Flexima® by B. Braun Medical Sas — 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 | 403923900000019427 | Class I | Active |
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Manufacturer
- Manufacturer
- B. Braun Medical Sas
- EUDAMED SRN
- FR-MF-000000674
Sources (1)
- EUDAMED a2532aea-8487-4aa8-ab42-9127d7beacc2 61 fields · synced Aug 1, 2026