WhtNavi

by Guangdong Optomedic Technologies, Inc. 3 variants

Ref 4010021Model OPTO-CAM104K

WhtNavi (4010021) is an endoscopic video image processing unit (EU MDR Class I; FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Guangdong Optomedic Technologies, Inc., cleared under FDA 510(k) K221781 on 2 Feb 2023, registered in EUDAMED on 29 Dec 2022 (Basic UDI-DI 697303129CAM000039A) and listed in FDA GUDID since 25 Mar 2024 (UDI-DI 06973031299917), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221781

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number06973031299917 UDI-DI	Date25 Mar 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK221781	Date2 Feb 2023Decided	StatusActive
European Union	CE/MDR EUDAMED	Number697303129CAM000039A Basic UDI-DI 06973031299917UDI-DI	Date29 Dec 2022Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 697303129CAM000039A — open Devices and search for it
AccessGUDID record UDI-DI 06973031299917
FDA 510(k) database 510(k) number K221781

Across registries

3 registries list this device

FDA 510(k) K221781 decided 2 Feb 2023 Active
EUDAMED Basic UDI-DI 697303129CAM000039A registered 29 Dec 2022 Active
FDA GUDID UDI-DI 06973031299917 listed 25 Mar 2024 Listed

Timeline

3 dated events

29 Dec 2022 Registered EUDAMED 697303129CAM000039A
2 Feb 2023 Cleared FDA 510(k) K221781
25 Mar 2024 Listed FDA GUDID 06973031299917

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: WhtNavi EUDAMED
Image Processing Unit GUDID
Generic name: Endoscopic video image processing unit
Model / reference: OPTO-CAM104K, 4010021

Primary DI / UDI-DI: 06973031299917
Basic UDI-DI: 697303129CAM000039A
510(k) Number: K221781
FDA product code: GCJ
EMDN code: Z12020406 Video processors
GMDN term: Endoscopic video image processing unit

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

Field	EUDAMED	GUDID
Device class	EUDAMED 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 VIDEO PROCESSORS.

Other devices from Guangdong Optomedic Technologies, Inc.

Insufflator(with Insufflation Tube and Gas Filter)

Class IIb
OptoMedic 4K UHD Medical Monitor

Class I
Stellar 3D Camera Head

Class I
Stellar Imaging System

Class II

See all devices from Guangdong Optomedic Technologies, Inc. →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (22, all answered No)