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BERCHTOLD GMBH & CO. KG

Germany · Tuttlingen

✓ 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

7listed device types

Class I 5Class II 2Class III 0

plus 7 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

18active ARTG entries

Class I 18

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 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.

United States7 registration records, 19 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia12 confirmed, 0 excluded

Manufacturer names merged into this page: BERCHTOLD GMBH & CO. KG · BERCHTOLD GMBH & CO KG · Berchtold GmbH & Co. KG

FDA 510(k) clearances by year

31992

41994

11995

11996

11997

11998

21999

12002

12003

22008

12009

12012

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K120392	CHROMOPHARE F 628 AND F 528	2012-02-16
US	K090378	CHROMOPHARE E 668	2009-02-23
US	K083066	CHROMOPHARE E 778 AND E 558	2008-10-30
BR	80005430406	Mesas cirúrgicas Operon	Class I
BR	80005430427	FOCOS CIRÚRGICOS CHROMOPHARE	Class I
SA	ME0000002949SFDAA00013	Berchtold Operon D850 Surgical Table	—
SA	ME0000002949SFDAA00017	Berchtold Chromophare®	—

BERCHTOLD 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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