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Laparoscope 20533WC

by Guangdong Optomedic Technologies, Inc. EUDAMEDGUDID

Active European Union

Ref 20533WCModel 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973031299610 UDI-DIDate26 Mar 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697303129YJ02SA01S9 Basic UDI-DIDate14 Jun 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Laparoscope
Generic Name
Rigid optical laparoscope
Model / Reference
20533WC, 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA
Primary DI / UDI-DI
06973031299610
Basic UDI-DI
697303129YJ02SA01S9
Direct Marketing DI
06973031299610
510(k) Number
FDA Product Code
GCJ, HET, NMH
EMDN Code
Z12029009 Laparoscopes
GMDN Term
Rigid optical laparoscope
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500, 884.1720
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K231003)

Other devices from Guangdong Optomedic Technologies, Inc.

See all devices from Guangdong Optomedic Technologies, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No