Identity
- Trade Name
- Premium Rom Elleboog Brace EUDAMED
- Device Name
- Premium Rom Elleboog Brace EUDAMED
- Model / Reference
- EB POP 1805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08718873037055 EUDAMED
- Basic UDI-DI
- 8718873EBPOP1805LZ EUDAMED
- EMDN Code
- Y060618 ELBOW-WRIST 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
Premium 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 | 8718873EBPOP1805LZ | Class I | Active |
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Manufacturer
- Manufacturer
- Lomed Nederland
- EUDAMED SRN
- NL-MF-000032807
Sources (1)
- EUDAMED a5224a2a-e2ab-438d-b449-2c3863be1657 61 fields · synced Jun 18, 2026