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Plastic Optical Frames without lenses

by Mr.Gain s.r.o. Czech Republic EUDAMED

Ref Prima NEAL black solid 57/18/145 EMDN Q02100203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8596554MRGPEY Basic UDI-DIDate7 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Plastic Optical Frames without lenses
Model / Reference
Prima NEAL black solid 57/18/145
Primary DI / UDI-DI
08596554014669
Basic UDI-DI
8596554MRGPEY
EMDN Code
Q02100203 Metal and plastic spectacle frames without lenses
Device Class
Class I
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000020808

Other devices from Mr.Gain s.r.o.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: 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

Sources (1)

  • EUDAMED 83587370-9a67-4e17-ac2d-4b43e404a6bb 61 fields · synced 22 Oct 2026