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WhtNavi

by Guangdong Optomedic Technologies, Inc. 3 variants

Ref 4020015Model OPTO-LED104K

WhtNavi (4020015) is a device classified as Class I in the EU and Class II in the US made by Guangdong Optomedic Technologies, Inc., registered in EUDAMED on 29 Dec 2022 (Basic UDI-DI 697303129LED00003D4) and listed in FDA GUDID since 26 Mar 2024 (UDI-DI 06973031299894), 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
United StatesGUDID listing GUDID Number06973031299894 UDI-DI Date26 Mar 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697303129LED00003D4 Basic UDI-DI 06973031299894UDI-DIDate29 Dec 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697303129LED00003D4 registered 29 Dec 2022 Active
  • FDA GUDID UDI-DI 06973031299894 listed 26 Mar 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697303129LED00003D4
  2. Listed FDA GUDID 06973031299894

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  • Withdrawn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
WhtNavi EUDAMED
WhtNavi Light Source GUDID
Generic name
Endoscopic video image processing/light source system
Device name
Light Source
Model / reference
OPTO-LED104K, 4020015
Primary DI / UDI-DI
06973031299894
Basic UDI-DI
697303129LED00003D4
FDA product code
NTN
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic video image processing/light source system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

Related devices

Category: Endoscopic light source unit, line-powered

Similar devices in this category

Other devices filed under LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY.

Other devices from Guangdong Optomedic Technologies, Inc.

See all devices from Guangdong Optomedic Technologies, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)