Identity
- Trade Name
- NM LOWZONE GEL2 CONTOUR CUSH EUDAMED
- Device Name
- MEDIUM EQUAZONE CUSHION EUDAMED
- Model / Reference
- LLEQM EUDAMEDLL2GC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05050962271876 EUDAMED
- Basic UDI-DI
- 5050962CUSHIONS7L EUDAMED
- Direct Marketing DI
- 05050962271876 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
Nm Lowzone Gel2 Contour Cush 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 6ac99f69-1b00-49bd-bfe0-a6e279223066 61 fields · synced Oct 6, 2026