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Aoj-20E

by Shenzhen AOJ Medical Technology Co., Ltd

Ref AOJ-20C

Aoj-20E is a device classified as Class IIa in the EU and Class II in the US made by Shenzhen AOJ Medical Technology Co., Ltd, registered in EUDAMED on 22 Mar 2024 (Basic UDI-DI B-06972040110176) and listed in FDA GUDID since 16 Oct 2019 (UDI-DI 06972040110176), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06972040110176 Basic UDI-DI 06972040110176UDI-DIDate22 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06972040110176 UDI-DI Date16 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06972040110176 registered 22 Mar 2024 Active
  • FDA GUDID UDI-DI 06972040110176 listed 16 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06972040110176
  2. Registered EUDAMED B-06972040110176

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  • Withdrawn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
Infrared Thermometer
Generic name
Infrared patient thermometer, skin
Model / reference
AOJ-20C EUDAMED
AOJ-20E GUDID
Primary DI / UDI-DI
06972040110176
Basic UDI-DI
B-06972040110176
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
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AOJ-20C
GUDID
AOJ-20E
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Infrared patient thermometer, skin

Similar devices in this category

Other devices filed under NON-CONTACT DIGITAL THERMOMETERS.

Other devices from Shenzhen AOJ Medical Technology Co., Ltd

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Properties

  • Single use
  • Measuring function
  • Over-the-counter
  • Manufacturing date
Other properties (19, all answered No)