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KENPAX INTERNATIONAL LIMITED

Hong Kong, China SAR · Hongkong · www.kenpax.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN HK-MF-000021152

This company has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 12

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

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2Class Is (sterile) 3

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 Union369 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States6 registration records, 4 510(k), 0 PMA

United Kingdom12 confirmed, 0 excluded

Manufacturer names merged into this page: KENPAX INTERNATIONAL LIMITED

Regulatory identity

EU manufacturer SRN: HK-MF-000021152
EU authorised representative: MedPath GmbH
UK responsible person: MedPath Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04895237104098	Sterile Equipment Covers	Class I
EU	04895237104067	Sterile Equipment Covers	Class I
EU	74895237113143	Disposable Underpads	Class I
EU	74895237113303	Disposable Underpads	Class I
UK	45171	Operation Room Towel	Class I
UK	58934	Baby Blanket	Class I
UK	35492	Isolation Gown	Class I
US	K222128	Protective Gown AAMI Level 4	2023-08-08
US	K222151	Sterilization Wrap	2023-03-23
US	K212504	Isolation Gown AAMI Level 3	2021-11-07

KENPAX INTERNATIONAL LIMITED

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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