HomeGermanyem-tec GmbH

em-tec GmbH

Germany · Finning
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 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
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class Im (measuring) 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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.

European Union192,018 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States3 registration records, 3 510(k), 0 PMA, 12 excluded
United Kingdom0 confirmed, 600 excluded
Brazil0 confirmed, 36 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: EM TECH.INC · EM-TEC GMBH

Company information

Country
Germany
City
Finning
Product categories
Components, Modules & SystemsElectronics, Electrical Engineering & Sensor TechnologyComponent-Oriented: Sensor TechnologyPressure, Flow, Temperature, Motion, Position, Particle & Gas Sensors (Manufacturing & Monitoring)

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
EM-Tec Test Systems GmbH
LEI
529900L8QBNDRNXAG952
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
2025-11-20
Registered address
Lindenallee 40, Sauensiek, 21644
Registration authority
Commercial Register, no. HRB 211915
Registry record updated
2026-03-09

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12004 · K040909
12008 · K080704
12012 · K111730

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Needle, Aspiration And Injection, Disposable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK111730SONOTT FLOWLAB(R)2012-01-06
USK080704LOW FLUID ALARM2008-04-17
USK040909SONO TT ULTRASONIC FLOWCOMPUTER2004-04-20

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