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SIMEX MEDIZINTECHNIK GMBH

Germany · Deisslingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Singapore, Israel, 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

46listed device types

Class I 44Class II 2Class III 0

plus 48 registration records and 3 510(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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States48 registration records, 3 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: SIMEX MEDIZINTECHNIK GMBH

FDA 510(k) clearances by year

12012 · K113291

12014 · K141255

12016 · K150459

FDA listed device types

showing 8 of 46

Dilator, Catheter 1Curette, Periodontic 1Chisel (Osteotome) 1Elevator 1Gouge, Surgical, General & Plastic Surgery 1Chisel, Surgical, Manual 1Clamp 1Handle, Scalpel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150459	FloSure Ventilation Patch	2016-01-05
US	K141255	SIMEX SUBGLOTTIC ASPIRATION SYSTEM	2014-09-22
US	K113291	SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300	2012-08-30

SIMEX 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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