HomeGermanyGentherm Medical GmbH

Gentherm Medical GmbH

Germany · Leinfelden-Echterdingen · www.gentherm.com
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class IIb 3
BRBrazilANVISA
4registered devices
Class I 3Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
5active device licences
Class II 5
16 including historic records
TWTaiwanTFDA
6valid device licences
Class II 6
SGSingaporeHSA SMDR
4device registrations
CLASS C 4
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIb 1
HKHong KongMDACS
2valid listings
Class II 1Class III 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 0 510(k), 0 PMA
United Kingdom3 confirmed, 0 excluded
Brazil4 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: Gentherm Medical, LLC · GENTHERM MEDICAL, LLC · GENTHERM MEDICAL LLC.

Regulatory identity

UK responsible person
Advena Ltd

Company information

Country
Germany
City
Leinfelden-Echterdingen
Website
www.gentherm.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Pack, Hot Or Cold, Water Circulating 1Controller, Temperature, Cardiopulmonary Bypass 1System, Thermal Regulating 1

Registration details (sample)

MarketIdentifierNameClass / date
UK36954FilteredFlo® Pediatric Blanket 55” x 40” (139.7cm x 101.6cm)Class IIb
UK36954Heating Unit (Air) - WarmAir / 220-240VClass IIb
UK36956Heating unit, pad, water/air - Maxi Therm Lite Head WrapClass IIb
BR80271290038MANTA WARM AIRClass I
BR80271290040COLCHÃO PARA SISTEMA DE HIPO-HIPERTERMIAClass I
BR80271290041MANTA FILTEREDFLO WARM AIRClass I
CA26796BLANKETROL II HYPO-HYPERTHERMIAClass II
CA68204MICRO-TEMP HEAT THERAPY SYSTEMClass II
CA68483WARMING TUBES AND BLANKETSClass II

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