Identity
- Trade Name
- Rollator elan plus EUDAMED
- Device Name
- Rollator elan plus 60, champagner EUDAMED
- Model / Reference
- 11441501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048792047328 EUDAMED
- Basic UDI-DI
- 4048792MO01004FX EUDAMED
- EMDN Code
- Y120609 WALKING FRAMES WITH CHAIR, 4 WHEELS 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
Rollator elan plus by Ludwig Bertram 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 | 4048792MO01004FX | Class I | Active |
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Manufacturer
- Manufacturer
- Ludwig Bertram GmbH
- EUDAMED SRN
- DE-MF-000013037
Sources (1)
- EUDAMED 1b24879e-ca93-4612-b794-a0f9282bbf38 61 fields · synced Jul 27, 2026