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Infrared Forehead Thermometer

by Shenzhen Pango Medical Electronics Co., Ltd EUDAMED510(k)GUDID

Active European Union and United States

Ref V0301010202Model PG-IRT1602,PG-IRT1612, PG-IRT1618, PG-IRT1603、PG-IRT1613、PG-IRT1615

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620184373-02 Date20 Aug 2026IssuedStatusActive expires 25 Jul 2029
United StatesGUDID listing GUDID Number06948423808824 UDI-DIDate17 Apr 2020ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK182597 Date3 Apr 2019IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Infrared Forehead Thermometer EUDAMED
nfrared Ear/Forehead Thermometers EUDAMED
Infrared Thermometer GUDID
Generic Name
Infrared patient thermometer, ear/skin
Device Name
Infrared Ear/Forehead Thermometer
Model / Reference
PG-IRT1602, PG-IRT1612, PG-IRT1618, V0301010202, PG-IRT1603、PG-IRT1613、PG-IRT1615, PG-IRT1603
Primary DI / UDI-DI
06948423808824, 06948423808763
Basic UDI-DI
6948423814313B7, 6948423814320B4
510(k) Number
FDA Product Code
FLL
EMDN Code
V0301010202 Non-contact digital thermometers
GMDN Term
Infrared patient thermometer, ear/skin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.2910
Market of Registration
Croatia
Poland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PG-IRT1602,PG-IRT1612, PG-IRT1618
V0301010202
PG-IRT1603、PG-IRT1613、PG-IRT1615
GUDID
PG-IRT1602
PG-IRT1603
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000023018
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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