Identity
- Trade Name
- Lumex EUDAMED
- Device Name
- Clinical Care Recliners EUDAMED
- Model / Reference
- FR587W8504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M368FR587W85041 EUDAMED
- Basic UDI-DI
- ++M368CLINICALRECLINER2P EUDAMED
- Direct Marketing DI
- M368FR587W85041 EUDAMED
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS 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
Lumex by GF Health Products, Inc. — 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 | ++M368CLINICALRECLINER2P | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GF Health Products, Inc.
- EUDAMED SRN
- US-MF-000002167
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 4b8d82be-b626-44fe-bf84-b9f66c32bd78 61 fields · synced Jun 9, 2026