FDA Registration
Active
🇩🇪 Germany
Heager GmbH
Reg #: 3015976667
·
FEI: 3015976667
·
Expires 2026
Products
20
Proprietary Names
38
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- Heager GmbH
- Registration Number
- 3015976667
- FEI Number
- 3015976667
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Friedrich Elbert Strabe, 111/117
- City
- HAAN North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K153513
Owner / Operator
- Firm Name
- Heager GmbH
- Operator Number
- 10061429
- Address
- 2228 E ROANOKE DR
- City
- Boise
- State
- ID
- Postal Code
- 83712
- Country
- US
- Correspondent
- Rex Frazier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2019-10-17 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-04-01 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2025-04-01 |
| Insufflator, Vaginal | HEC | Class 1 | Obstetrics/Gynecology | No | 2021-09-04 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2019-10-17 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-05-10 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2019-10-17 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-05-10 |
| Transformer, Endoscope | GCW | Class 2 | Gastroenterology, Urology | No | 2019-10-17 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2024-05-10 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-05-10 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2019-10-17 |
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2024-05-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-09-06 |
| Digitizer, Image, Radiological | LMA | Class 2 | Radiology | No | 2021-09-04 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2024-12-31 |
| Colposcope (And Colpomicroscope), Exempt | PTZ | Class 2 | Obstetrics/Gynecology | No | 2019-10-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-09-06 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-09-01 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2019-10-17 |
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 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
HEAGER GmbH Colposcope Model Heager HD Colpo 2 with Accessories
Heager GmbH Orthopedic Surgical Instrument Model Heager TorquePro
Heager GmbH Orthopedic Motor AC Powered Model Heager OrthoDrive
HEAGER GMBH SABRINA LASER
Heager GmbH Sheath and Sharp Trocar 7mm, 10mm , 6mm, 11mm, 12mm
Heager GmbH Sheath And Safety shield Trocar 5mm, 6mm, 7mm,10mm,11mm and 12mm
Heager GmbH Sheath and Sharp Trocar 5mm
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device