Identity
- Trade Name
- e-fix EUDAMED
- Device Name
- e-fix E35 EUDAMED
- Model / Reference
- e-fix E35 EUDAMED1595822 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046727256647 EUDAMED
- Basic UDI-DI
- 4046727e-fixE35QZ EUDAMED
- EMDN Code
- Y122410 ELECTRIC PROPULSION UNIT 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
e-fix by Alber 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 | 4046727e-fixE35QZ | Class I | Active |
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Manufacturer
- Manufacturer
- Alber GmbH
- EUDAMED SRN
- DE-MF-000005502
Sources (1)
- EUDAMED 693c0d82-a90b-49e2-a2ee-7165972cfbae 61 fields · synced May 23, 2026