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Infant Lid Speculum. D10-5350

by Daud Jee Mfg. Co

Ref D10-5350Model D10-5000-9019

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++G006OphthalSpeculumU8 Basic UDI-DI +G006D10535004UDI-DIDate5 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number+G006D10535004 UDI-DI Date13 Dec 2022ListedStatusListed 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  • Withdrawn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

Trade Name
Infant Lid Speculum.
Generic Name
Eyelid speculum, reusable
Device Name
Ophthalmic Speculums
Model / Ref / Catalog
D10-5350, D10-5000-9019
Primary DI / UDI-DI
+G006D10535004 EUDAMED
G006D1053500 GUDID
Basic UDI-DI
++G006OphthalSpeculumU8
FDA Product Code
HNC
EMDN Code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN Term
Eyelid speculum, reusable
Device Class
Class I
Regulation Number
886.4350
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+G006D10535004
GUDID
G006D1053500

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Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No