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KH Medical GmbH

Germany · Helmbrechts · www.kh-medical.de

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United Kingdom, Brazil — 2 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

IVD A 1

BRBrazilANVISA

5registered devices

Class I 4Class II 1

7 including historic records

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

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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.

European Union3,643 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 4 excluded

United Kingdom1 confirmed, 8 excluded

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: KH MEDICAL CO.LTD. · KH MEDICAL CO. LTD. (PYEONGTAEK) · KH MEDICAL CO LTD

Regulatory identity

UK responsible person: MT Promedt Consulting Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
UK	52521	RADI PREP Swab and Stool DNA/RNA Kit	IVD A
BR	80430080009	RADI Transport Medium (RTM)	Class I
BR	80430080004	RADI PREP SWAB AND STOOL DNA / RNA KIT	Class I
BR	80430080006	RADI PREP PLUS SWAB E STOOL DNA/RNA KIT AUTOMATIZADO	Class I

KH Medical GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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