Identity
- Trade Name
- PU COVER & PEQPM SET EUDAMED
- Device Name
- MEDIUM EQUAZONE CUSHION EUDAMED
- Model / Reference
- LLEQM EUDAMEDPEQPMSB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05050962368330 EUDAMED
- Basic UDI-DI
- 5050962CUSHIONS7L EUDAMED
- Direct Marketing DI
- 05050962368330 EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER 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
Pu Cover & Peqpm Set by Helping Hand Company (Ledbury) Ltd — 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 | 5050962CUSHIONS7L | Class I | Active |
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Manufacturer
- Manufacturer
- Helping Hand Company (Ledbury) Ltd
- EUDAMED SRN
- GB-MF-000011951
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (1)
- EUDAMED fe99615d-60db-4ffe-9b65-48fedef4a00b 61 fields · synced Jun 19, 2026