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Data / Medical devices / Germany / Heager GmbH

Heager GmbH: FDA-registered device maker in HAAN North Rhine-Westphalia, Germany, 9 510(k) clearances

Heager GmbH is registered with the FDA (registration 3015976667) in HAAN North Rhine-Westphalia, Germany. It lists 18 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 26, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Heager GmbH
FDA registration number
3015976667
Address
Friedrich Elbert Strabe 111/117, HAAN North Rhine-Westphalia, Germany, 42781
Owner or operator
Heager GmbH (10061429)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 17, 2019
Registered through
2027
Brand names listed
Gasoflator Insufflation Tubing Set (REF GAS-INS-01), HEAGER GMBH SABRINA LASER, HEAGER GmbH 4G Arthroscope, HEAGER GmbH 4G Gyne Laparoscope , HEAGER GmbH 4G Hysteroscope, HEAGER GmbH Colposcope Model Heager HD Colpo 2 with Accessories, HEAGER GmbH Endoscopy Camera System HD 8866 with Image Display System, HEAGER GmbH Endoscopy Camera System HDEIS with Image Display System, HEAGER GmbH Endoscopy Camera System HUMIS 4K ICG, Art No:- HG-HUM-4K-ICG-001 with Image Display System and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Colposcope (And Colpomicroscope), ExemptPTZ2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Repackager or relabeleraccessdata.fda.gov
Digitizer, Image, RadiologicalLMA2Repackager or relabeleraccessdata.fda.gov
Display, Diagnostic RadiologyPGY2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Repackager or relabeleraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Repackager or relabeleraccessdata.fda.gov
Transducer, Ultrasonic, ObstetricHGL2Repackager or relabeleraccessdata.fda.gov
TrocarDRC2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 26, 2025K250261Heager Medical Laser Family (Sabrina/Adolf)GEXSubstantially EquivalentHeager GmbHaccessdata.fda.gov
September 7, 2023K221743Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical ElectrodesGEISubstantially EquivalentJiangsu Bonss Medical Technology Co., Ltd.accessdata.fda.gov
June 9, 2023K230728JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD MonitorPGYSubstantially EquivalentNanjing Jusha Display Technology Co., Ltd.accessdata.fda.gov
March 25, 2022K212231C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD MonitorPGYSubstantially EquivalentNanjing Jusha Display Technology Co., Ltd.accessdata.fda.gov
March 21, 2013K123335SUNRAY FETAL MONITORHGMSubstantially EquivalentSunray Medical Apparatus Co., Ltd.accessdata.fda.gov
January 8, 2013K121261ASAP MUITISCOPEHRXSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov
September 29, 2003K031974ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0HIHSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov
September 15, 2003K031972ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,HRXSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov
June 30, 2003K031141ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPEFAJSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov

Compare with other makers

Updated August 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.