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Adtemp™ 429

by American Diagnostic Corporation

Ref NT16Model 3106445000

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471095342TCF03NTXM2 Basic UDI-DI 00634782083472UDI-DIDate18 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00634782083472 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

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 found in the data synced 23 Oct 2026.

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  • Withdrawn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
Touch Free Infrared Thermometer EUDAMED
Adtemp™ GUDID
Generic Name
Infrared patient thermometer, skin
Model / Ref / Catalog
3106445000 EUDAMED
NT16 EUDAMED
429 GUDID
Primary DI / UDI-DI
00634782083472
Basic UDI-DI
471095342TCF03NTXM2
Direct Marketing DI
00634782083472
510(k) Number
FDA Product Code
FLL
EMDN Code
V0301010202 Non-contact digital thermometers
GMDN Term
Infrared patient thermometer, skin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.2910
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
3106445000
NT16
GUDID
429
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K081160)

Show all (12)

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Measuring Function
  • Over-the-Counter
  • Lot / Batch Number

Other properties (21)

  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No