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TM441

by ADLINK Technology GmbH

Ref 93-KS43G-UH10

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260657690344 UDI-DI Date23 Aug 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number426065769TM441000G3 Basic UDI-DI 04260657690344UDI-DIDate22 Jun 2022RegisteredStatusActive

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.

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  • Withdrawn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

Generic Name
Image display unit, colour
Device Name
Surgical Monitor TM441
Model / Ref / Catalog
93-KS43G-UH10, TM441
Primary DI / UDI-DI
04260657690344
Basic UDI-DI
426065769TM441000G3
FDA Product Code
KQM
EMDN Code
Y210999 Personal computer input and output peripheral equipment - other
GMDN Term
Image display unit, colour
Device Class
Class I
Regulation Number
878.4160
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
93-KS43G-UH10
GUDID
TM441

Manufacturer details

EUDAMED SRN
DE-MF-000012782

Other devices from Adlink Technology GmbH

See all devices from Adlink Technology GmbH →

Properties

  • Premarket Exempt
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No