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ECMO-Fix 1
EUDAMEDClass I (EU MDR)
Ref 100-300-01Model Fixierung für Katheterschlauchsysteme
Identity
- Trade Name
- ECMO-Fix 1 EUDAMED
- Model / Reference
- Fixierung für Katheterschlauchsysteme EUDAMED100-300-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260402640204 EUDAMED
- Basic UDI-DI
- 42604026424056 EUDAMED
- EMDN Code
- C030180 EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
ECMO-Fix 1 by Novo Klinik-Service GmbH — Class I — 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 | 42604026424056 | Class I | Active |
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Manufacturer
- Manufacturer
- Novo Klinik-Service GmbH
- EUDAMED SRN
- DE-MF-000005289
Sources (1)
- EUDAMED 698f4b7f-f95e-44ff-8e9f-2c2663f43211 61 fields · synced Jun 19, 2026