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VCA Lite Q033-G00-01

by Pce, Inc.

Ref Q033-G00-01

VCA Lite Q033-G00-01 is a vaginal applicator (EU MDR Class I; FDA Class I; FDA product code HGD, Applicator, Vaginal) made by Pce, Inc., registered in EUDAMED on 27 Apr 2026 (Basic UDI-DI 08600094929Q033K7) and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 00860009492905), 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 Number08600094929Q033K7 Basic UDI-DI 00860009492905UDI-DIDate27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860009492905 UDI-DI Date11 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08600094929Q033K7 registered 27 Apr 2026 Active
  • FDA GUDID UDI-DI 00860009492905 listed 11 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00860009492905
  2. Registered EUDAMED 08600094929Q033K7

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  • Withdrawn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
VCA Lite
Generic name
Vaginal applicator, single-use
Model / reference
Q033-G00-01
Primary DI / UDI-DI
00860009492905
Basic UDI-DI
08600094929Q033K7
Unit of use DI
20860009492909
FDA product code
HGD
EMDN code
U089009 Vaginal applicators, single-use
GMDN term
Vaginal applicator, single-use
Device class
Class I
Regulation number
884.4520
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vaginal applicator, single-use

Similar devices in this category

Other devices filed under DEVICES FOR GYNECOLOGY - VARIOUS.

Other devices from Pce, Inc.

Properties

  • Single use
  • Administering medicine
  • Measuring function
  • Prescription use
  • Over-the-counter
  • Premarket exempt
Other properties (19, all answered No)