HomeGermanyAckermann Instrumente GmbH

Ackermann Instrumente GmbH

Germany · Rietheim-Weilheim · www.ackermannsurgical.com
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, 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
0UDI-DI device records
USUnited StatesFDA openFDA
58listed device types
Class I 46Class II 12Class III 0
plus 56 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
133registered device records
Class I 111Class IIa 16Class IIb 6
BRBrazilANVISA
33registered devices
Class I 26Class II 7
38 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
32active device licences
Class II 32
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
30active ARTG entries
Class I 30
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
8registrations
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 States56 registration records, 3 510(k), 0 PMA
United Kingdom133 confirmed, 0 excluded
Brazil33 confirmed, 2 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada32 confirmed, 0 excluded
Manufacturer names merged into this page: ACKERMANN INSTRUMENTE GMBH · Ackermann Instrumente GmbH

Regulatory identity

UK responsible person
MEDAGENT INTERNATIONAL UK LIMITED

Company information

Country
Germany
City
Rietheim-Weilheim
Website
www.ackermannsurgical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instrumentsCardiology & vascular medicineOphthalmologyWomen’s Health, Neonatology & Pediatric CarePediatric care & pediatric medical technologiesPediatric medical devices & interfaces

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

LEI
5299006Q9WYQ1IH38B31
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1998-02-02
Registration authority
Commercial Register, no. HRB 450964
Registry record updated
2026-07-27

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

11998 · K974382
12011 · K111930
12015 · K143450

FDA listed device types

showing 8 of 58
Punch, Nasal 1Rasp 1Scissors, Medical, Disposable 1Probe 1Camera, Television, Endoscopic, Without Audio 1Tube, Tonsil Suction 1Mirror, General & Plastic Surgery 1Handle, Scalpel 1

Registration details (sample)

MarketIdentifierNameClass / date
UK38654Shaver blade, reusable, Agressive Full Radius Resector 3.5mm for Ackermann/Arthrex shaver systemsClass IIa
UK41499Shaver blade, disposable, Agressive Full Radius Resector 3.4mm for Dyonics shaver systemsClass IIa
UK36224Arthroscopy shaver unit incl. footswitch and handpiece (Ackermann/Arthrex compatible)Class IIa
USK143450Ackermann Intervertebral Body Fusion Device2015-09-16
USK111930ACKERMANN EUROPCLIP2011-11-08
USK974382ACKERMANN SURGICAL INSTRUMENTS1998-04-21
BR10349009008Passador de sutura reutilizável do Sistema de Fechamento De FásciaClass II
BR80302210011FONTE DE LUZClass II
BR10349000564Aplicadores de clipes para cirurgias abertasClass I
SAME0000000302SFDAA00002VersaOne
CA25244ELECTRODESClass II
CA34431LAPAROSCOPIC TIPS - STAINLESS STEELClass II
CA35268LAPAROSCOPIC HANDLESClass II

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