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ChM sp. z o.o.

Poland · Juchnowiec Koscielny · www.chm.eu

✓ Record-verifiedregistrations found in 9 marketsEU SRN PL-MF-000002121

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥95, 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

≥95UDI-DI device records

Class I 95

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

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 1Class IIb 2

BRBrazilANVISA

27registered devices

Class I 27

42 including historic records

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union20,580 raw hits, 5 excluded, 95 confirmed. Large result set — only the first 300 verified

United States0 registration records, 1 510(k), 0 PMA

United Kingdom3 confirmed, 8 excluded

Brazil27 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: CHM SP. Z O.O. · ChM Sp. zo.o. · ChM sp. z o.o.

Regulatory identity

EU manufacturer SRN: PL-MF-000002121
UK responsible person: Regulatus Ltd

Business registration

Legal name: CHM 2 Sp. z o.o.
LEI: 259400SQ8SV7UGAV5210
Registration status: Active
Legal form: spółka z ograniczoną odpowiedzialnością (sp. z o.o.)
Incorporated: 2013-07-05
Registered address: UL. CHMIELNA 71, WARSZAWA, 00-801
Registration authority: National Court Register, no. 0000468464
Registry record updated: 2025-10-08

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05908447106406	—	Class I
EU	05908447075207	—	Class I
EU	05908447288041	—	Class I
EU	05908447379749	—	Class I
UK	44759	Instruments for 7.0ChLP	Class I
UK	66947	7.0ChLP cancellous conical screw 5.4	Class IIb
UK	46647	7.0ChLP anterior arthrodesis plate TT	Class IIb
US	K210490	ChM 4.5mm Cortical screws	2021-10-05
BR	80530180104	Instrumental para Sistema de Mãos ChM	Class I
BR	80530180088	Instrumental para Fixação Pélvica Acetabular Master ChM	Class I
BR	80530180105	Instrumental para Sistema Úmero ChM	Class I
SA	ME0000006453SFDAA00025	Tourniquet	—

ChM sp. z o.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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