HomeGermanyHeager GmbH

Heager GmbH

Germany · Haan North Rhine-Westphalia
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 6Class II 14Class III 0
plus 20 registration records and 1 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States20 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: Heager GmbH

Company information

Country
Germany
City
Haan North Rhine-Westphalia

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.

FDA 510(k) clearances by year

12025 · K250261

FDA listed device types

showing 8 of 20
Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Insufflator, Endoscopic Vessel Harvesting 1Lamp, Operating-Room 1Arthroscope 1Hysteroscope (And Accessories) 1Colposcope (And Colpomicroscope), Exempt 1Display, Diagnostic Radiology 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250261Heager Medical Laser Family (Sabrina/Adolf)2025-08-26

Similar companies

1st German Health Resilience Conference
Germany · markets 0
3B Scientific GmbH
Germany · markets 1
3R LifeScience GmbH
Germany · markets 0
6th International Sports Pharmacy Symposium
Germany · markets 0
A&D Verpackungsmaschinenbau GmbH
Germany · markets 0
A. u. K. Müller GmbH & Co. KG
Germany · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →