FDA Registration
Active
🇦🇺 Australia
Medical Resale PTY Limited
Reg #: 3011416394
·
FEI: 3011416394
·
Expires 2026
Products
25
Proprietary Names
144
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- Medical Resale PTY Limited
- Registration Number
- 3011416394
- FEI Number
- 3011416394
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3/2 Otranto Avenue
- City
- Caloundra QLD Queensland
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K182234
Owner / Operator
- Firm Name
- Medical Resale PTY Limited
- Operator Number
- 10047901
- Address
- 3/2 Otranto Avenue
- City
- Sunshine Coast
- State
- Queensland
- Postal Code
- 4551
- Country
- AU
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2025-11-18 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2025-11-18 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2023-02-21 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-02-21 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2015-02-05 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2015-02-05 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2015-02-05 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2015-01-14 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2026-02-06 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2015-12-29 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-05-09 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2021-02-23 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2019-01-21 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2019-01-21 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2015-03-24 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2017-01-31 |
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | Class 2 | Gastroenterology, Urology | No | 2015-01-14 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2024-06-20 |
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | Class 1 | Radiology | No | 2025-04-16 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2017-02-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-01 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2023-02-21 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2017-05-25 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2019-01-03 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2015-03-17 |
Proprietary Names
2020 GE Optima XR240 Gen 2 ANZ 1
2020 GE Optima XR240 Gen 2 ANZ 2
ENF-VH
ENF-V3
Toshiba Ultrasound Probe
Probe
Gastroscopes, EG 2990 I PENTAX
GE Discovery NM/CT 570C
L15-7IO TRANSDUCER
D2CWC STATIC TRANSDUCER
C5-1 TRANSDUCER
S5-1 TRANSDUCER
L12-5 50MM TRANSDUCER
C9-2 TRANSDUCER
S8-3 TRANDUCER, COMPACT
L12-5 50 TRANSDUCER
L12-3 TRANSDUCER
X6-1 TRANSDUCER
L18-5 TRANSDUCER
C10-3V TRANSDUCER
C8-5 TRANSDUCER
V6-2 TRANSDUCER
C10-4EC TRANSDUCER
TRANSDUCER L12-5 50 COMPACT
GE Infinia 3/8" Hawkeye 4 GP3 SPECT/CT
Voluson i/e
Siemens Ultrasound Probes
P5-1 probe
Philips Brilliance iCT 256
Philips Epiq 7G Ultrasound equipment
Hologic Insight Mini C-Arm
GE Voluson S6 System
GE BrightSpeed Elite CT
GE OEC 9800 Mobile II
GE ML6-15-D Ultrasound Probe
Philips Transducer
Biograph mCT 128
Toshiba Xario XG
Fujinon Colonoscope
Axiom Artis
Processor Pentax EPK-i
Artis Zee Biplane
Lightspeed VCT 64 Slice
Olympus Endoscopy
Hawkeye 1
GE Discovery VCT PET CT
GE Probe
COLONOSCOPES: EC3890 Fi2 PENTAX
Siemens YSIO Rad room
EPIQ 7
Logiq P6
Allura FD10 rel 7/2
OEC 9900 Elite
GE Discovery 690
GE Innova 2100
IG530
Siemens S2000 Ultrasound systems
Siemens S2000 Probes
RAB4-8-D probe
RNA5-9-D probe
Philips Brightview XCT
GE Venue 40
S4-10-D probe
L8-18I-D probe
RIC5-9-D probe
C2-6b-D probe
S4-10-D transducer
3Sp-D probe
10C-D probe
GE RIC5-9-D Ultrasound Probe
11L-D probe
6S-D probe
M5S- D
IC5-9-D Probe
Vivid T8 R2
Performix 40 Plus tube housing
Epiq 7C
GE Optima 660 CT
ML6-15 probe
RAB2-6-RS probe
GE Venue R2 ultrasound system
GE 3T HDxt MRI
Philips S5-1
GE Voluson E10 BT15 system with probes
3Sc-RS probe
6S-RS probe
4Z1C probe
Evis Exera II
L8-18i-RS probe
STRYKER LIGHTSOURCE
GE Optima 450W
Siemens Acuson Probes
Olympus 180 Endoscopy Equipment
Toshiba Aplio MX
Philips Ingenuity CT
CLV-190
Laryngoscopy equipment
Olympus endoscopy
C2-9-D probe
8C probe
9L-D probe
C1-6-D probe
IC5-9 V NAV BRACKET
Millennium MG Gamma Camera
VF16-5 probe
VF12-4 probe
P4-2 probe
C8F3 4D probe
Siemens 1.5T Magnetom ESPREE MRI
Sonosite ultrasound
GE Discovery 690 PET CT
GE Discovery 710
RAB6-D Ultrasound Probe
Stryker 1188
GE Discovery 670
L10-22-RS probe
C9-4V TRANSDUCER
VL13-5 TRANSDUCER
TRANSDUCER, BP10-5EC
L12-4 TRANSDUCER
C6-2 TRANSDUCER
GE Innova 3100
ENF-GP
Siemens Somatom Definition CT Scanner
GE 1.5 Excite HDXT 16X MRI System
Philips IU22 Ultrasound Probes
Siemens Symbia
CT660
OEV-262H
4C-SC probe
RAB6-D probe
VF8-3 probe
IE33
S4-1 Transducer
L17-5 Transducer
Biograph Horizon 16-3R
GE Innova 2100-IQ
Luminos Agile
pentax A120251 DSU EB 1970K No 62 and pentax G120362 DSU EB 1970K
GE VCT - Lightspeed
DISCOVERY CT750 HD
CF-H180AL Colonoscope
CX-50
Toshiba Aquilion TSX 101-A
Establishment Types
Export Device to the United States But Perform No Other Operation on Device