Identity
- Trade Name
- FlexFlo EUDAMED
- Device Name
- FlexFlo Bags Sodium Chloride for Irrigation EUDAMED
- Model / Reference
- BMCCB7127S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05413760231419 EUDAMED
- Basic UDI-DI
- 0085412GMN00000000002197E EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
FlexFlo by Baxter Healthcare SA — Class IIb — 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 | 0085412GMN00000000002197E | Class IIb | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare SA
- EUDAMED SRN
- CH-MF-000026124
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (1)
- EUDAMED db9da789-2a8f-44bf-a52c-9ce1b7c61de5 61 fields · synced Jun 19, 2026