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Alphamed UFR118

by Shenzhen Urion Technology Co., Ltd

Alphamed UFR118 is a Class II device made by Shenzhen Urion Technology Co., Ltd, cleared under FDA 510(k) K200802 on 7 Oct 2020, registered in EUDAMED and listed in FDA GUDID since 19 Mar 2021 (UDI-DI 06953825907563), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200802

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06953825907563 UDI-DI Date19 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200802 Date7 Oct 2020DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K200802 decided 7 Oct 2020 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 06953825907563 listed 19 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200802
  2. Listed FDA GUDID 06953825907563

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Alphamed
Generic name
Infrared patient thermometer, ear/skin
Model / reference
UFR118
Primary DI / UDI-DI
06953825907563
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, ear/skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, ear/skin

Cleared under the same submission (K200802)

and 8 more cleared under K200802

Similar devices in this category

Other devices filed under Infrared patient thermometer, ear/skin.

Other devices from Shenzhen Urion Technology Co., Ltd

See all devices from Shenzhen Urion Technology Co., Ltd →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)