Identity
- Device Name
- Gel Bunion Protector EUDAMED
- Model / Reference
- SA4112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05018632309762 EUDAMED
- Basic UDI-DI
- 5018632SA1AS EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Gel Bunion Protector by Paul Murray plc — 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 | 5018632SA1AS | Class I | Active |
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Manufacturer
- Manufacturer
- Paul Murray plc
- EUDAMED SRN
- GB-MF-000009853
- Authorised Representative
- Murrays Health and Beauty Europe Limited IE-AR-000003274
Sources (1)
- EUDAMED c3ee873b-5921-48b0-9067-b7ecf4f16444 61 fields · synced Jul 8, 2026