Home›Germany›SUTTER MEDIZINTECHNIK GMBH

SUTTER MEDIZINTECHNIK GMBH

Germany · Emmendingen

✓ Record-verifiedregistrations found in 9 markets

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

5listed device types

Class I 1Class II 4Class III 0

plus 17 registration records and 10 510(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

1 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

10active ARTG entries

Class I 5IIb 5

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States17 registration records, 10 510(k), 0 PMA, 4 excluded

Manufacturer names merged into this page: SUTTER MEDIZINTECHNIK GMBH

FDA 510(k) clearances by year

11999

12008

12013

12015

12018

22019

12020

12024

12026

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Arthroscope 1Nasopharyngoscope (Flexible Or Rigid) 1Lavage, Jet 1Tray, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251813	CURIS II RF Generator (REF 360100-05)	2026-02-11
US	K233425	FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)	2024-01-25
US	K193587	Sutter Swyng non-stick bipolar forceps, single-use	2020-02-10