Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015976667

FEI Number

3015976667

Entity Name

Heager GmbH

City/State/Country

HAAN North Rhine-Westphalia, DE

Establishment Address

Friedrich Elbert Strabe, 111/117, HAAN North Rhine-Westphalia 42781, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Heager GmbH (Owner Number: 10061429)

Owner / Operator Contact Address

2228 E ROANOKE DR, Boise, ID 83712, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Heager GmbH Hysteroscope System Heager GmbH INSUFFLATOR MODEL GASOFLATOR 30 LT WITH SMOKE REDUCTION FACILITY Heager GmbH INSUFFLATOR MODEL GASOFLATOR 50 LT WITH SMOKE REDUCTION FACILITY Heager GmbH INSUFFLATOR MODEL GASOFLATOR 40 LT WITH SMOKE REDUCTION FACILITY HEAGER GmbH Hysteroscopy Insufflator Model Hysterojet With Suction HEAGER GmbH Hysteroscopy Insufflator Model Hysterojet HEAGER GmbH HYSTEROSCOPY PUMP MODEL HYSTEROJET WITH STANDARD ACCESSORIES HEAGER GmbH 4G Arthroscope Heager GmbH Laparoscopic Set for Tubal Ligation Heager GmbH Laparoscopic Hand Instrument Set for Lapcholy Heager GmbH Laparoscpic Hand Instruments Set for Lap Assisted Vaginal Hysterectomy HEAGER GmbH MULTISCOPE HEAGER GmbH ESOPHAGOGASTRODUODENOSCOPES; HEAGER GmbH FIBEROPTIC ILLUMINATORS FOR ENDOSCOPES, INCANDESCENT LAMP HEAGER GmbH FLEXIBLE & RIGID CHOLEDOSCOPES; HEAGER GmbH NEPHROSCOPES; HEAGER GmbH PROCOTOSCOPES HEAGER GmbH RESECTOSCOPES; HEAGER GmbH RIGID ADULT & PEDIATRIC BRONCHOSCOPE & ACCESSORIES HEAGER GmbH DIAGONISTIC CYSTOSCOPE; HEAGER GmbH ENDOMAGNETIC RETRIEVERS; HEAGER GmbH ENTROSCOPE HEAGER GmbH ANOSCOPE; HEAGER GmbH BILIARY PANCREATOSCOPES; HEAGER GmbH COLONOSCOPE; HEAGER GmbH CYSTOURETHROSCOPE HEAGER GmbH RIGID ESOPHAGOSCOPES; HEAGER GmbH SIGMOIDOSCOPES; HEAGER GmbH URETERORENOSCOPES; HEAGER GmbH URETHROSCOPES HEAGER GmbH 4G Gyne Laparoscope , HEAGER GmbH 4G Hysteroscope HEAGER GmbH Endoscopy Camera System HUMIS 4K with Image Display System HEAGER GmbH Endoscopy Camera System HUMIS with Image Display System HEAGER GmbH Endoscopy Camera System HUMIS II with Image Display System HEAGER GmbH Endoscopy Camera System HDEIS with Image Display System HEAGER GmbH Endoscopy Camera System HD 8866 with Image Display System HEAGER GmbH Endoscopy Camera System HUMIS 4K ICG, Art No:- HG-HUM-4K-ICG-001 with Image Display System Heager GmbH Medical Grade Monitor 32 Inches HEAGER GmbH 4G Arthroscope Heager GmbH Medical Grade Monitor 27 Inch Display Heager GmbH Radio Frequency Plasma Surgical Electrodes Model Heager Plasma Blade Electrodes Heager GmbH Radio Frequency Plasma Surgical Systems Model Heager PlasmaWave HEAGER GmbH HD Recording and Image Storage Device Heager GmbH OT Lamp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2019-10-17
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-04-01
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2025-04-01
HEC	Insufflator, Vaginal	Obstetrics/Gynecology	Class 1	884.5920	2021-09-04
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2019-10-17
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-05-10
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2019-10-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-05-10
GCW	Transformer, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2019-10-17
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-05-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-05-10
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2019-10-17
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-05-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-05-10
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-05-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-06
LMA	Digitizer, Image, Radiological	Radiology	Class 2	892.2030	2021-09-04
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2024-12-31

Official Correspondent

Rex Frazier

US Agent Details

Rex Frazier Email: rexhowardfrazier@gmail.com Phone: (208) 8415472

Related Public Records

Same Entity

Heager GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015976667. Last updated year: 2026. Please use registration number 3015976667 when referencing this establishment in official correspondence.