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Ac-5000

by Alltion (Guangxi) Instrument Co., Ltd.

Ref manyModel AC-5000

Ac-5000 (many) is a colposcope (EU MDR Class I; FDA Class II; FDA product code PTZ, Colposcope (And Colpomicroscope), Exempt) made by Alltion (Guangxi) Instrument Co., Ltd., registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI 697044351AC5000YK) and listed in FDA GUDID since 9 Sep 2026 (UDI-DI 06970443510326), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970443510326 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697044351AC5000YK Basic UDI-DI 06970443510326UDI-DIDate21 Apr 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697044351AC5000YK registered 21 Apr 2026 Active
  • FDA GUDID UDI-DI 06970443510326 listed 9 Sep 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697044351AC5000YK
  2. Listed FDA GUDID 06970443510326

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  • Withdrawn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
Ac-5000 EUDAMED
Alltion GUDID
Generic name
Colposcope
Model / reference
AC-5000, many
Primary DI / UDI-DI
06970443510326
Basic UDI-DI
697044351AC5000YK
Direct marketing DI
06970443510326
FDA product code
PTZ
EMDN code
Z12020703 Colposcopes
GMDN term
Colposcope
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.1630
EU registration type
Standard device
EU market of registration
Belgium
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-000024670
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under COLPOSCOPES.

Other devices from Alltion (Guangxi) Instrument Co., Ltd.

See all devices from Alltion (Guangxi) Instrument Co., Ltd. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)