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HEINE OPTOTECHNIK GMBH & CO. KG.

Germany · Gilching

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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

pendingnot queried

USUnited StatesFDA openFDA

22listed device types

Class I 14Class II 8Class III 0

plus 27 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 8Class II 2

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

SASaudi ArabiaSFDA

71registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

8 including historic records

TWTaiwanTFDA

10valid device licences

Class I 8Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

27active ARTG entries

Class I 26Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

11active registrations

Class 1 2Class 2a 9

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.

United States27 registration records, 7 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Saudi Arabia71 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: HEINE OPTOTECHNIK GMBH & CO. KG. · HEINE OPTOTECHNIK GMBH & CO. KG · HEINE Optotechnik GmbH & Co. KG · HEINE Optotechnik GmbH & Co. KG. · Heine Optotechnik GMBH Co KG

FDA 510(k) clearances by year

12010 · K101892

32013 · K131961

12014 · K131959

22015 · K142486

FDA listed device types

showing 8 of 22

Transilluminator, Battery-Powered 1Light, Examination, Medical, Battery Powered 1Chart, Visual Acuity 1Lens, Condensing, Diagnostic 1Laryngoscope, Rigid 1Stethoscope, Manual 1Loupe, Binocular, Low Power 1Device, Medical Examination, Ac Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142486	HEINE BETA 200, HEINE BETA 200 S, HEINE K 180	2015-05-18
US	K142837	HEINE SIGMA 250 & HEINE SIGMA 250 M2	2015-01-29
US	K131959	HEINE MINI 3000(R) OPHTHALMOSCOPE	2014-03-07
BR	10243860043	ESTETOSCOPIO GAMMA HEINE	Class I
BR	10243860044	ESFIGMOMANÔMETRO GAMMA HEINE	Class II
BR	10243869007	FOTOFORO	Class I
SA	ME0000004869SFDAA00001	MICROLIGHT2 MPACK MINI	—
SA	ME0000004869SFDAA00002	Otoscoopes	—
CA	11576	GLAUCOTEST THRESHOLD TONOMETER	Class II
CA	63568	HEINE INFRARED EAR THERMOMETER EN 100T	Class II

HEINE OPTOTECHNIK GMBH & CO. KG.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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