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S.I.M.E.O.N. Medical GmbH & Co.KG

Germany · Tuttlingen · www.simeonmedical.com

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Israel — 5 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

7listed device types

Class I 4Class II 3Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 1Class IIb 1

BRBrazilANVISA

2registered devices

Class I 2

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

5valid device licences

Class I 4Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 Union714,378 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States9 registration records, 0 510(k), 0 PMA, 8,881 excluded

United Kingdom2 confirmed, 1,822 excluded

Brazil2 confirmed, 2,571 excluded

Saudi Arabia0 confirmed, 968 excluded

Canada0 confirmed, 1,238 excluded

Manufacturer names merged into this page: S.I.M.E.O.N. MEDICAL GMBH & Co.KG · S.I.M.E.O.N MEDICAL GMBH & CO.KG

Regulatory identity

UK responsible person: GK Wood & Son Ltd t/a Fulbourn Medical

FDA listed device types

Light, Surgical, Floor Standing 1Light, Surgical, Accessories 1Light, Surgical, Ceiling Mounted 1Camera, Surgical And Accessories 1Light, Examination, Medical, Battery Powered 1Table, Operating-Room, Electrical 1Device, Medical Examination, Ac Powered 1

Market	Identifier	Name	Class / date
UK	35630	SimCarry	Class IIb
UK	37332	Examination Lights	Class I
BR	10331310022	Foco Cirúrgico Sim.LED	Class I
BR	10331310023	Foco Cirúrgico Sim.LED	Class I

S.I.M.E.O.N. Medical GmbH & Co.KG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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