Skip to content

IT Multi-unit Analog IC0MAN43H

by WARANTEC.Co., Ltd

Ref IC0MAN43H

IT Multi-unit Analog IC0MAN43H is a Class I device made by WARANTEC.Co., Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-08800026105138) and listed in FDA GUDID since 12 Apr 2023 (UDI-DI 08800026105138), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800026105138 Basic UDI-DI 08800026105138UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026105138 UDI-DI Date12 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800026105138 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 08800026105138 listed 12 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800026105138
  2. Registered EUDAMED B-08800026105138

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
IT Multi-unit Analog
Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device name
Multi-unit Analog_Hex
Model / reference
IC0MAN43H
Primary DI / UDI-DI
08800026105138
Basic UDI-DI
B-08800026105138
FDA product code
NDP
EMDN code
Q010207 Dental impression devices for prosthetic dentistry
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class I
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from WARANTEC.Co., Ltd

See all devices from WARANTEC.Co., Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)