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Brilliance OT

by Changzhou Sifary Medical Technology Co., Ltd. 15 variants

Ref 5080990Model ibT5035T, ibT5040T, ibT5045T, ibT5050T

Brilliance OT (5080990) is a Class I device made by Changzhou Sifary Medical Technology Co., Ltd., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 697259778IB011LJ) and listed in FDA GUDID since 6 May 2026 (UDI-DI 06941877825287), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697259778IB011LJ Basic UDI-DI 06941877825287UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941877825287 UDI-DI Date6 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697259778IB011LJ registered 8 May 2026 Active
  • FDA GUDID UDI-DI 06941877825287 listed 6 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06941877825287
  2. Registered EUDAMED 697259778IB011LJ

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  • Withdrawn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
ibT5035T, ibT5040T, ibT5045T, ibT5050T, 5080990
Primary DI / UDI-DI
06941877825287
Basic UDI-DI
697259778IB011LJ
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 registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ibT5035T, ibT5040T, ibT5045T, ibT5050T
5080990
GUDID
ibT5050T

Manufacturer details

EUDAMED SRN
CN-MF-000010405
Authorised representative
Caretechion GmbH DE-AR-000005946

Similar devices in this category

Other devices filed under HELMETS AND BINOCULAR GLASSES FOR SURGEONS.

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 (22, all answered No)