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Fltr PC801

by Shenzhen Pacom Medical Instruments Co., Ltd.

Ref PC801

Fltr PC801 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-10840061480109), cleared under FDA 510(k) K190717 on 13 Dec 2019 and listed in FDA GUDID since 26 Sep 2020 (UDI-DI 10840061480109), 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) K190717

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-10840061480109 Basic UDI-DI 10840061480109UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10840061480109 UDI-DI Date26 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190717 Date13 Dec 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10840061480109 registered 4 Nov 2026 Active
  • FDA 510(k) K190717 decided 13 Dec 2019 Active
  • FDA GUDID UDI-DI 10840061480109 listed 26 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190717
  2. Listed FDA GUDID 10840061480109
  3. Registered EUDAMED B-10840061480109

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  • Withdrawn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
Fltr
Generic name
Infrared patient thermometer, ear/skin
Model / reference
PC801
Primary DI / UDI-DI
10840061480109 EUDAMED
00840061480119 GUDID
Basic UDI-DI
B-10840061480109
510(k) Number
FDA product code
FLL
EMDN code
V0301010201 Contact digital thermometers (including probes)
GMDN term
Infrared patient thermometer, ear/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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10840061480109
GUDID
00840061480119
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10840061480109; FDA GUDID lists 00840061480119), so their flags are not compared. 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, ear/skin

Cleared under the same submission (K190717)

Similar devices in this category

Other devices filed under CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES).

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)