Identity
- Trade Name
- Polsbrace 8'' EUDAMED
- Device Name
- Polsbrace 8'' EUDAMED
- Model / Reference
- PB PO 1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08718873036942 EUDAMED
- Basic UDI-DI
- 8718873PO1101YH EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Polsbrace 8'' 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 | 8718873PO1101YH | Class I | Active |
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Manufacturer
- Manufacturer
- Lomed Nederland
- EUDAMED SRN
- NL-MF-000032807
Sources (1)
- EUDAMED e44a3d15-04d7-4722-a2d2-5fcc98f3c3e5 61 fields · synced Jun 18, 2026