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EGZOTech Sp. z.o.o.

✓ Record-verifiedregistrations found in 9 marketsEU SRN PL-MF-000003826

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Taiwan, Singapore, Australia, Hong Kong, Israel — 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

6UDI-DI device records

Class I 1Class IIa 5

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 IIa 2

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

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

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

2registrations

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 Union6 raw hits, 0 excluded, 6 confirmed

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

United Kingdom3 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: EGZOTech Sp. z o.o.

Regulatory identity

EU manufacturer SRN: PL-MF-000003826
UK responsible person: THOR ASSISTIVE TECHNOLOGIES LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05903228161995	Meissa OT Pro	Class IIa
EU	05903228161049	Meissa OT Ultra	Class IIa
EU	05903228161902	Sidra LEG Ultra	Class IIa
EU	05903228161889	Sidra LEG Pro	Class IIa
UK	11474	Stella Bio	Class IIa
UK	38447	Mezos SIT - an examination and treatment chair designed to support and position the patient	Class I
UK	64759	Luna EMG	Class IIa
US	K210002	STELLA BIO	2021-10-01
SA	ME0000022375SFDAA00003	Mezos SIT	—

EGZOTech Sp. z.o.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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