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Baxter Medical Systems GmbH + Co. KG

Germany · Saalfeld Thuringia

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel, Russia — 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

13listed device types

Class I 7Class II 6Class III 0

plus 23 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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 2Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

25active ARTG entries

Class I 24IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 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 States23 registration records, 0 510(k), 0 PMA, 40 excluded

Brazil7 confirmed, 12 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 11 excluded

Manufacturer names merged into this page: Baxter Medical Systems GmbH + Co. KG · Baxter Medical Systems (Suzhou) Co. Ltd · BAXTER MEDICAL SYSTEMS GMBH + CO. KG

FDA listed device types

showing 8 of 13

Light, Surgical, Floor Standing 1Light, Surgical, Ceiling Mounted 1Table, Radiologic 1Lamp, Operating-Room 1Light, Surgical, Instrument 1Lamp, Surgical 1Table, Surgical With Orthopedic Accessories, Ac-Powered 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1

Market	Identifier	Name	Class / date
BR	80102512691	LUZ CIRÚRGICA iLED 7	Class I
BR	80102512640	Mesa de Operações	Class I
BR	80102512439	Mesa de Operações	Class I

Baxter Medical Systems GmbH + Co. KG

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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