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IMDS Operations B.V.

Netherlands · Roden Groningen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

2listed device types

Class I 0Class II 2Class III 0

plus 8 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

5active ARTG entries

Class III 5

HKHong KongMDACS

7valid listings

Class IV 7

ILIsraelAMAR

3registrations

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 States8 registration records, 9 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: IMDS Operations B.V. · IMDS HOLDING B.V. ATA IMDS OPERATIONS B.V., IMDS SERVICES B.V. AND IMDS PLASTICS B.V. · IMDS OPERATIONS B.V.

Same-named companies — This database also contains companies with near-identical names: IMDS HOLDING B.V. ATA IMDS OPERATIONS B.V., IMDS SERVICES B.V. AND IMDS PLASTICS B.V.. Company name alone cannot separate their registrations, so the figures below may include either.

Market	Identifier	Name	Class / date
US	K260559	NHanceIT	2026-08-14
US	K242337	FlowGuide (FG60F); GuidionShort (GS60F)	2025-04-17
US	K241611	ShapeIT (SI014135)	2024-09-03

IMDS Operations 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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