Identity
- Device Name
- Miniflow procedure pack EUDAMED
- Model / Reference
- 4000-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04060139100114 EUDAMED
- Basic UDI-DI
- 4060139000122G EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The miniflow is a single-use product for non-invasive respiratory support and oxygen therapy of newborn infants. It is used in combination with a ventilator or bubble CPAP device which supplies the necessary gas flow to generate the CPAP pressure. The miniflow is used under the supervision of competent personnel trained for this purpose in a clinical environment. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Miniflow procedure pack by medin Medical Innovations GmbH — Class IIa — 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 | 4060139000122G | Class IIa | Active |
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Manufacturer
- Manufacturer
- medin Medical Innovations GmbH
- EUDAMED SRN
- DE-PR-000036234
Sources (1)
- EUDAMED 296fe3ae-051f-42ac-aad8-cf38be0b84f8 61 fields · synced Jul 8, 2026