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Light Guide Cable

by Guangdong Optomedic Technologies, Inc.

Ref FIB-H3045Model FIB-H3045, FIB-H3545, FIB-H3035

Light Guide Cable (FIB-H3045) is a medical device (EU MDR Class I; FDA Class II) made by Guangdong Optomedic Technologies, Inc., registered in EUDAMED on 26 Sep 2024 (Basic UDI-DI 697303129WS0701EV) and listed in FDA GUDID since 18 Aug 2023 (UDI-DI 06973031299795), 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 Number697303129WS0701EV Basic UDI-DI 06973031299795UDI-DIDate26 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06973031299795 UDI-DI Date18 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697303129WS0701EV registered 26 Sep 2024 Active
  • FDA GUDID UDI-DI 06973031299795 listed 18 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06973031299795
  2. Registered EUDAMED 697303129WS0701EV

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  • Withdrawn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
Light Guide Cable EUDAMED
Amnotec GUDID
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Model / Ref / Catalog
FIB-H3045 EUDAMED
FIB-H3545 EUDAMED
FIB-H3035 EUDAMED
71-146-30 NIR C-US GUDID
Primary DI / UDI-DI
06973031299795
Basic UDI-DI
697303129WS0701EV
Direct marketing DI
06973031299795
FDA product code
GCJ, IZI
EMDN code
Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 892.1600
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Dry Heat Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FIB-H3045, FIB-H3545, FIB-H3035
FIB-H3045
GUDID
71-146-30 NIR C-US
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000011588
Authorised representative
Share info GmbH DE-AR-000005132

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES.

Other devices from Guangdong Optomedic Technologies, Inc.

See all devices from Guangdong Optomedic Technologies, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)