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FlexFlo
EUDAMEDClass IIb (EU MDR)
Ref ADCCB7127SRef AECCB7119SRef AECCB7129SRef AECCB7319SRef BMCCB7317SRef 14318B7GRRef ADCCB2165SRef BLCCB7319SRef AECCB7317SRef BMCCB7129SRef XACCB7317SRef BLCCB7119SRef BLCCB7129S
Identity
- Trade Name
- FlexFlo EUDAMED
- Device Name
- FlexFlo Bags Sodium Chloride for Irrigation EUDAMEDFlexFlo Bags Sterile water for irrigation EUDAMEDFlexFlo Bags Glycine for irrigation EUDAMEDFlexFlo Bags Ringer lactate for irrigation EUDAMED
- Model / Reference
- ADCCB7127S EUDAMEDAECCB7119S EUDAMEDAECCB7129S EUDAMEDAECCB7319S EUDAMEDBMCCB7317S EUDAMED14318B7GR EUDAMEDADCCB2165S EUDAMEDBLCCB7319S EUDAMEDAECCB7317S EUDAMEDBMCCB7129S EUDAMEDXACCB7317S EUDAMEDBLCCB7119S EUDAMEDBLCCB7129S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05413760169125 EUDAMED05413760169712 EUDAMED05413760169286 EUDAMED05413760169026 EUDAMED05413760231471 EUDAMED05413760197111 EUDAMED05413760169071 EUDAMED05413760231389 EUDAMED05413760169316 EUDAMED05413760231457 EUDAMED00197886010503 EUDAMED05413760231341 EUDAMED05413760231365 EUDAMED
- Basic UDI-DI
- 0085412GMN00000000002197E EUDAMED0085412GMN00000000002206X EUDAMED0085412GMN00000000002177A EUDAMED0085412GMN00000000002187C 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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Also classified as Device sterilization/disinfection container, reusable.
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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 | 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 (13)
- EUDAMED baf1d687-d8a0-4e2f-a01a-fec3dd2e9202 61 fields · synced Aug 4, 2026
- EUDAMED 8b6046ed-a9ac-482b-aba2-d606e11028a5 61 fields · synced May 16, 2026
- EUDAMED 3c0a595e-7f85-4579-aee1-fe6629f21422 61 fields · synced May 17, 2026
- EUDAMED 6a5f73a0-133d-4dc9-86e6-40cdfa4063f9 61 fields · synced May 17, 2026
- EUDAMED 5f39b45f-4c82-46bf-9c0c-e93261343df2 61 fields · synced May 17, 2026
- EUDAMED 1d95e9f5-0762-4781-8d2a-4159da5b594b 61 fields · synced May 17, 2026
- EUDAMED c1b65610-b9c8-4022-ab07-e802aa091dea 61 fields · synced May 17, 2026
- EUDAMED 4c656ba4-838d-45e9-ac79-3e7e9902f5af 61 fields · synced May 17, 2026
- EUDAMED 7dab37cb-e06a-4167-9ec4-8d62c819b181 61 fields · synced May 17, 2026
- EUDAMED b93ca672-8dd8-49dd-b438-551d059040f3 61 fields · synced May 17, 2026
- EUDAMED f613f5fd-9540-4be5-9273-5031c6dbca91 61 fields · synced May 17, 2026
- EUDAMED 64831b97-4f5c-4f7f-9e7c-dfbc0262ae12 61 fields · synced May 18, 2026
- EUDAMED a8267be4-b11d-45c2-9f93-9f1219d1b6ee 61 fields · synced May 18, 2026