FDA Registration
Active
🇦🇺 Australia
IAN JAMIESON PTY LTD
Reg #: 3008386005
·
FEI: 3008386005
·
Expires 2026
Products
26
Proprietary Names
1
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- IAN JAMIESON PTY LTD
- Registration Number
- 3008386005
- FEI Number
- 3008386005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 64-68 Collie Street
- City
- Fyshwick Australian Capital Territory
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K221690
Owner / Operator
- Firm Name
- Ian Jamieson Pty Ltd
- Operator Number
- 10053388
- Address
- 64-68 Collie Street
- City
- Fyshwick
- State
- Australian Capital Territory
- Postal Code
- 2609
- Country
- AU
- Correspondent
- Ian Jamieson
US Agent
- Business Name
- Innovative Endoscopy Components LLC
- Contact Name
- Gerald Goigitzer
- Address
- 320 International Pkwy
- City
- Sunrise
- State
- FL
- ZIP
- 33325
- Country
- US
- [email protected]
- Phone
- 954 2178780
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-09-03 |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2018-06-03 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2018-06-03 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2019-05-12 |
| Enteroscope And Accessories | FDA | Class 2 | Gastroenterology, Urology | No | 2019-05-12 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2016-11-30 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2016-11-30 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2019-05-25 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2019-08-23 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-10-22 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2018-09-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-11-23 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2024-11-23 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2019-08-23 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2025-07-13 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2018-01-10 |
| Ultrasound Bronchoscope | PSV | Class 2 | Radiology | No | 2018-01-10 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2023-11-19 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2023-06-26 |
| Urethroscope | FGC | Class 2 | Gastroenterology, Urology | No | 2023-06-26 |
| Telescope, Rigid, Endoscopic | FBP | Class 2 | Gastroenterology, Urology | No | 2023-06-26 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2017-12-05 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2017-12-05 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2017-12-05 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2019-08-22 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2019-08-22 |
Proprietary Names
P series ENF
Establishment Types
Export Device to the United States But Perform No Other Operation on Device