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Lumex

by GF Health Products, Inc. 233 variants

Ref FR601P8516

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++M368CLINICALRECLINER2P Basic UDI-DI M368FR601P85161UDI-DIDate14 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberM368FR601P85161 UDI-DI Date3 Jan 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Reclining chair
Device Name
Clinical Care Recliners
Model / Reference
FR601P8516
Primary DI / UDI-DI
M368FR601P85161
Basic UDI-DI
++M368CLINICALRECLINER2P
Direct Marketing DI
M368FR601P85161
FDA Product Code
INM
EMDN Code
V080202 Manual medical chairs
GMDN Term
Reclining chair
Device Class
Class I
Regulation Number
890.3100
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000002167
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from GF Health Products, Inc

See all devices from GF Health Products, Inc →

Properties

  • Premarket Exempt
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No