Identity
- Trade Name
- Empulse F55 EUDAMED
- Device Name
- E-Mobility device EUDAMED
- Model / Reference
- F55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050063058780 EUDAMED
- Basic UDI-DI
- 4050063emobilityMJ EUDAMED
- Direct Marketing DI
- 04050063058780 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
Empulse F55 by Sunrise Medical 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 | 4050063emobilityMJ | Class I | Active |
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Manufacturer
- Manufacturer
- Sunrise Medical GmbH
- EUDAMED SRN
- DE-MF-000006320
Sources (1)
- EUDAMED 6345a9e7-505c-40d5-a521-46f2c508aa38 61 fields · synced Jun 19, 2026