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drainova® Drainage-Pack
EUDAMEDClass I (EU MDR)
Ref 50-7550Model gravity reservoir
by ewimed GmbH
Identity
- Trade Name
- drainova® Drainage-Pack EUDAMED
- Device Name
- drainova® Drainage-Pack EUDAMED
- Model / Reference
- gravity reservoir EUDAMED50-7550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04060559000360 EUDAMED
- Basic UDI-DI
- 4060559EW1000494 EUDAMED
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Das Schwerkraftreservoir (Art. Nr. 50-7250) der Behandlungseinheit drainova® Drainage-Pack (Art. Nr. 50-7550) dient als Sammelbehälter bei der intermittierenden Drainage von Ergussflüssigkeit z.B. Pleuraerguss oder Aszites. Das Schwerkraftreservoir besitzt zur Konnektierung an Drainagekatheter einen LuerLock männlich-Anschluss und zusätzlich ist ein Adapter LuerLock weiblich-weiblich (Art. Nr. 5206634) enthalten. Für die Heimversorgung soll ein entsprechendes Verbandmaterial-Set (Art. Nr. 8020) beigepackt werden. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Negative-pressure wound therapy system canister
drainova® Drainage-Pack by ewimed GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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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 | 4060559EW1000494 | Class I | Active |
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Manufacturer
- Manufacturer
- ewimed GmbH
- EUDAMED SRN
- DE-PR-000021827
Sources (1)
- EUDAMED 2b13f82e-3dbb-4a32-b4c2-82b10cdb590b 61 fields · synced Jun 14, 2026