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Scholly Fiberoptic GmbH

Germany · Denzlingen

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Singapore, South Korea, Israel — 6 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class II 11

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

SASaudi ArabiaSFDA

17registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

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.

United States0 registration records, 3 510(k), 0 PMA

Brazil11 confirmed, 1 excluded

Saudi Arabia17 confirmed, 0 excluded

Manufacturer names merged into this page: SCHOLLY FIBEROPTIC GMBH · Scholly Fiberoptic GMBH

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141366	VIDEO BRONCHOSCOPE SYSTEM	2014-12-17
US	K133682	SCHOELLY ARTHROSCOPE	2014-06-02
US	K984556	SCICAN CLASSIC	1999-02-09
BR	10302869015	Endoscópio para Artroscopia Mistra	Class II
BR	80370829037	Artroscópio	Class II
BR	10302869023	Endoscopio para Sinuscopia Mistra	Class II
SA	ME0000014755SFDAA00003	Controller 4K UHD USB Image Video Capture	—
SA	ME0000014755SFDAA00003	Controller 4K UHD USB Image Video Capture	—

Scholly Fiberoptic GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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