HomeGermanyKamedi GmbH

Kamedi GmbH

Germany · Karlsruhe · www.heatit.de
✓ Record-verifiedregistrations found in 6 marketsEU SRN DE-MF-000006270

This company has registrations in European Union, United States, United Kingdom, South Korea, Australia, Israel — 6 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
23UDI-DI device records
Class IIa 23
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 1System or Procedure Pack 1
BRBrazilANVISA
0registered devices
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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.

European Union23 raw hits, 0 excluded, 23 confirmed
United States1 registration records, 0 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: Kamedi GmbH

Regulatory identity

EU manufacturer SRN
DE-MF-000006270
UK responsible person
Qserve Group UK, Ltd.

Company information

Country
Germany
City
Karlsruhe
Website
www.heatit.de
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentEmergency, Rescue & Disaster Medicine

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.

Business registration

LEI
39120050MA4DOMJKSP56
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
2018-11-30
Registration authority
Commercial Register, no. HRB 732042
Registry record updated
2025-11-20

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Pad, Heating, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04262370290610heat it X QoQaClass IIa
EU04262370290719heat it classic USB-C (CZ+SK)Class IIa
EU04262370290634heat it classic USB-C (Nordics)Class IIa
EU04262370290290heat it unplugClass IIa
UK47103heat itClass IIa
UK47103heat itSystem or Procedure Pack

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