Identity
- Trade Name
- Rom Elleboog Brace EUDAMED
- Device Name
- Rom Elleboog Brace EUDAMED
- Model / Reference
- EB PO 1105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08718873037048 EUDAMED
- Basic UDI-DI
- 8718873EBPO11054D EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Rom Elleboog Brace by Lomed Nederland — 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 | 8718873EBPO11054D | Class I | Active |
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Manufacturer
- Manufacturer
- Lomed Nederland
- EUDAMED SRN
- NL-MF-000032807
Sources (1)
- EUDAMED d72858c6-ed0e-45d8-9341-62f7f5833bbd 61 fields · synced Jul 12, 2026