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Infrared Thermometer PC828

by Shenzhen Pacom Medical Instruments Co., Ltd.

Ref PC828

Infrared Thermometer PC828 is a device classified as Class IIa in the EU and Class II in the US made by Shenzhen Pacom Medical Instruments Co., Ltd., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-10840061482806), cleared under FDA 510(k) K172889 on 25 May 2018 and listed in FDA GUDID since 15 Apr 2020 (UDI-DI 00840061482809), active as of 7 Nov 2026.

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

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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172889

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10840061482806 Basic UDI-DI Date4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840061482809 UDI-DI Date15 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172889 Date25 May 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10840061482806 registered 4 Nov 2026 Active
  • FDA 510(k) K172889 decided 25 May 2018 Active
  • FDA GUDID UDI-DI 00840061482809 listed 15 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172889
  2. Listed FDA GUDID 00840061482809
  3. Registered EUDAMED B-10840061482806

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Infrared Thermometer
Generic name
Infrared patient thermometer, skin
Model / reference
PC828
Description
Model: PC828; Brand: None.
Primary DI / UDI-DI
00840061482809, 10840061482806
Basic UDI-DI
B-10840061482806, B-00840061482809
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 registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

Cleared under the same submission (K172889)

and 5 more cleared under K172889

Similar devices in this category

Other devices filed under NON-CONTACT DIGITAL THERMOMETERS.

Other devices from Shenzhen Pacom Medical Instruments Co., Ltd.

See all devices from Shenzhen Pacom Medical Instruments Co., Ltd. →

Properties

  • Measuring function
  • Over-the-counter
  • Lot / batch number
Other properties (20, all answered No)