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SIGNUS MEDIZINTECHNIK GMBH

Germany · Alzenau Bavaria

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Russia — 5 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

20listed device types

Class I 7Class II 13Class III 0

plus 31 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 6Class II 1

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 1Class II 2Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 1IIa 1IIb 14

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 3 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 States31 registration records, 25 510(k), 0 PMA, 2 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: SIGNUS MEDIZINTECHNIK GMBH · SIGNUS MEDIZINEN TECHNIK GMBH

FDA 510(k) clearances by year

11999

22004

32005

22006

32008

22009

22012

12013

22014

12016

12021

22022

12024

12025

12026

FDA listed device types

showing 8 of 20

Template 1Forceps 1Scissors, Orthopedic, Surgical 1Instrument, Manual, Surgical, General Use 1Instrument, Microsurgical 1Tray, Surgical, Instrument 1Orthopedic Manual Surgical Instrument 1Posterior Cervical Screw System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261031	POSEIDON ST	2026-07-10
US	K243188	CYLOX® ST	2025-02-11
US	K241438	Signus Tetris St; Signus Tetris R St	2024-09-11
BR	10210550112	CAIXA DE INSTRUMENTAL PARA CAGES DIANA®	Class I
BR	10210550083	CAIXA DE INSTRUMENTAL CERCCESS	Class I
BR	10210550111	INSTRUMENTAL PARA SISTEMA MONOPOLY	Class I

SIGNUS MEDIZINTECHNIK GMBH

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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