Identity
- Trade Name
- FlexFlo EUDAMED
- Device Name
- FlexFlo Bags Sterile water for irrigation EUDAMED
- Model / Reference
- BMCCB7117S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05413760231396 EUDAMED
- Basic UDI-DI
- 0085412GMN00000000002206X 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
Category: Device sterilization/disinfection container, reusable
FlexFlo by Baxter Healthcare SA — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0085412GMN00000000002206X | 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 68ead528-fade-457f-a873-fd4f3ec584f9 61 fields · synced Jun 18, 2026