Identity
- Device Name
- Comfort Shoulder Immobilizer EUDAMED
- Model / Reference
- 304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000304108 EUDAMED
- Basic UDI-DI
- 5063000304YX EUDAMED
- EMDN Code
- M030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Comfort Shoulder Immobilizer by Neo G Limited — 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 | 5063000304YX | Class I | Active |
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Manufacturer
- Manufacturer
- Neo G Limited
- EUDAMED SRN
- GB-MF-000004603
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 3c508a0f-bdd4-4e8c-8e99-060e3d0fdcb8 61 fields · synced Jun 18, 2026