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BAAT MEDICAL PRODUCTS B.V.

Netherlands · Hengelo Overijssel

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Australia — 3 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

10listed device types

Class I 1Class II 9Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

6valid device licences

Class II 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States9 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: BAAT MEDICAL PRODUCTS B.V.

FDA 510(k) clearances by year

12020 · K201830

12021 · K211474

12023 · K220966

22026 · K254176

FDA listed device types

showing 8 of 10

Rod, Fixation, Intramedullary And Accessories 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Intervertebral Fusion Device With Integrated Fixation, Lumbar 1Pin, Fixation, Threaded 1Growing Rod System 1Fastener, Fixation, Nondegradable, Soft Tissue 1

Market	Identifier	Name	Class / date
US	K254176	SINEFIX	2026-03-16
US	K251961	SDS Growing Rod	2026-01-15
US	K220966	SINEFIX	2023-03-08

BAAT MEDICAL PRODUCTS B.V.

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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