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Laparoscope

by Guangdong Optomedic Technologies, Inc. 8 variants

Ref 21033SAModel 21033SA,21033SC

Laparoscope (21033SA) is a rigid optical laparoscope (EU MDR Class IIa; FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Guangdong Optomedic Technologies, Inc., cleared under FDA 510(k) K241530 on 7 Aug 2024, registered in EUDAMED on 6 Jun 2023 (Basic UDI-DI 697303129YJ02FA01PE) and listed in FDA GUDID since 15 Aug 2024 (UDI-DI 06973031299344), 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) K241530

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973031299344 UDI-DI Date15 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241530 Date7 Aug 2024DecidedStatusActive
European UnionCE/MDR EUDAMED Number697303129YJ02FA01PE Basic UDI-DI 06973031299344UDI-DIDate6 Jun 2023RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K241530 decided 7 Aug 2024 Active
  • EUDAMED Basic UDI-DI 697303129YJ02FA01PE registered 6 Jun 2023 Active
  • FDA GUDID UDI-DI 06973031299344 listed 15 Aug 2024 Listed

Timeline

3 dated events

  1. Registered EUDAMED 697303129YJ02FA01PE
  2. Cleared FDA 510(k) K241530
  3. Listed FDA GUDID 06973031299344

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Laparoscope EUDAMED
3D Laparoscope GUDID
Generic name
Rigid optical laparoscope
Model / reference
21033SA, 21033SC
Primary DI / UDI-DI
06973031299344
Basic UDI-DI
697303129YJ02FA01PE
Direct marketing DI
06973031299344
510(k) Number
FDA product code
GCJ
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 LAPAROSCOPES.

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)