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Eighteeth ibT4050T

by Changzhou Sifary Medical Technology Co., Ltd.

Ref 5080986Model ibT4035T, ibT4040T, ibT4045T, ibT4050T

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697259778IB010LG Basic UDI-DI 06941877825249UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941877825249 UDI-DI Date30 Apr 2026ListedStatusListed 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  • Withdrawn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
Brilliance OT EUDAMED
Eighteeth GUDID
Generic Name
Surgical binoculars, reusable
Device Name
Surgical Binocular Loupes
Model / Ref / Catalog
ibT4035T, ibT4040T, ibT4045T, ibT4050T, 5080986
Primary DI / UDI-DI
06941877825249
Basic UDI-DI
697259778IB010LG
FDA Product Code
FSP
EMDN Code
L0316 Helmets and binocular glasses for surgeons
GMDN Term
Surgical binoculars, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ibT4035T, ibT4040T, ibT4045T, ibT4050T
5080986
GUDID
ibT4050T

Other devices from Changzhou Sifary Medical Technology Co., Ltd.

See all devices from Changzhou Sifary Medical Technology Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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