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Scleral Marker

by Gcmedica Enterprise Ltd.(Wuxi)

Ref GC1953A01U01、GC1953A01

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-GC1953A01U01MN Basic UDI-DI D-GC1953A01U01MNUDI-DIDate4 Nov 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Scleral Markers
Model / reference
GC1953A01U01、GC1953A01
Primary DI / UDI-DI
D-GC1953A01U01MN
Basic UDI-DI
B-GC1953A01U01MN
EMDN code
Q021199 Ophthalmic surgery instruments, single-use - other
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008756
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Gcmedica Enterprise Ltd.(Wuxi)

See all devices from Gcmedica Enterprise Ltd.(Wuxi) →

Properties

  • Supplied sterile

Other properties (13)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No