Identity
- Device Name
- Medijet procedure pack EUDAMED
- Model / Reference
- 1000-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04060139100046 EUDAMED
- Basic UDI-DI
- 4060139000112E EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The medijet is a single-use product for non-invasive respiratory support and oxygen therapy of newborn infants. It is used in combination with a CPAP driver which supplies the necessary gas flow to generate the CPAP pressure. The medijet is used under the supervision of competent personnel trained for this purpose in a clinical environment. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Pulmonary function analysis system, adult
Medijet procedure pack by medin Medical Innovations GmbH — Class IIa — 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 | 4060139000112E | Class IIa | Active |
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Manufacturer
- Manufacturer
- medin Medical Innovations GmbH
- EUDAMED SRN
- DE-PR-000036234
Sources (1)
- EUDAMED 5a7068f1-e637-46b4-b9b8-93f0dcc052b1 61 fields · synced Jul 28, 2026