FDA Registration
Active
🇯🇵 Japan
RADIA INDUSTRY CO., LTD.
Reg #: 9611680
·
FEI: 3002807969
·
Expires 2026
Products
24
Proprietary Names
103
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- RADIA INDUSTRY CO., LTD.
- Registration Number
- 9611680
- FEI Number
- 3002807969
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 168 Ooyagi
- City
- Takasaki Gunma
- Country
- JP
Owner / Operator
- Firm Name
- Radia Industry Co., Ltd.
- Operator Number
- 10042849
- Address
- 168 Ooyagi
- City
- Takasaki
- State
- Gunma
- Postal Code
- 370-0072
- Country
- JP
- Correspondent
- Masako Tomita
US Agent
- Business Name
- Globizz Corp.
- Contact Name
- Takahiro Haruyama
- Address
- 970 W. 190th St., Suite 200
- City
- Torrance
- State
- CA
- ZIP
- 90502
- Country
- US
- [email protected]
- Phone
- 310 5383860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-02-01 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2021-03-10 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-03-10 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2013-01-07 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2013-01-07 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-04-11 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2013-12-05 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2013-12-05 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2013-01-07 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-01-07 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2013-01-07 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-01-07 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
| Ligator, Esophageal | MND | Class 2 | Gastroenterology, Urology | No | 2013-01-07 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2013-01-07 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2013-01-07 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2024-04-11 |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2024-04-11 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2013-12-05 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2013-01-07 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2025-12-18 |
Proprietary Names
Steriject
Sterijekt
PENTAX Single Use Balloon OF-A67
PENTAX Single Use Balloon OE-A51
Safeshield Microscalpel
Microscalpel with plastic handle
AS-8313ASB ASB clear corn ang blade, 2.2mm (6/box)
AS-8316ASB ASB clear corn ang blade, 2.5mm (6/box)
AS-8324ASB ASB clear corn ang blade, 3mm (6/box)
AS-8312ASB ASB clear corn ang blade, 2mm (6/box)
AS-8318ASB ASB clear corn ang blade, 2.65mm (6/box)
AS-8321ASB ASB clear corn ang blade, 2.8mm (6/box)
Microscalpel with aluminum handle
DISPOSABLE BIOPSY FORCEPS FB series
FB-210U
FB-215U
FB-245U
FB-225U
FB-220K
FB-221K
FB-240U
FB-230K
FB-240K
FB-241K
FB-230U
FB-211K
FB-220U
FB-235U
FB-231K
Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2
Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1
CryotopCL
disposable lancet
disposable lancet sp
PENTAX Medical Single Use Balloon OE-A60
SINGLE USE BIOPSY VALVE
PENTAX Medical Single Use Balloon OE-A61
HX-610-135S
HX-610-090S
HX-610-090L
HX-610-135
HX-610-090
HX-610-135XS
HX-610-135L
ROTATABLE CLIP FIXING DEVICE HX series
Maeda New NeedleDisposable
DISPOSABLE SCALPEL NO.10
DISPOSABLE SCALPEL NO.15
DISPOSABLE SCALPEL NO.11
disposable scalpel
disposable scalpel mini
disposable dermatome
safeshield scalpel vessel
disposable scalpel deep
DISPOSABLE SCALPEL NO.12
DISPOSABLE SCALPEL NO.22
PENTAX Single Use Balloon OE-A56
DISPOSABLE HOT BIOPSY FORCEPS FD series
MAJ-2315
CARBON STEEL BLADE NO.22
surgical blade stainless steel
STAINLESS STEEL BLADE NO.25
STAINLESS STEEL BLADE NO.15
microsurgical blade for fine incision
CARBON STEEL BLADE NO.12
BLADE, SCALPEL
STAINLESS STEEL BLADE NO.12
skin graft knife blade, dermatome blade
CARBON STEEL BLADE NO.23
CARBON STEEL BLADE NO.10
CARBON STEEL BLADE NO.11
STAINLESS STEEL BLADE NO.11
STAINLESS STEEL BLADE NO.23
STAINLESS STEEL BLADE NO.15C
surgical blade carbon steel
dissecting blade
CARBON STEEL BLADE NO.25
STAINLESS STEEL BLADE NO.10
STAINLESS STEEL BLADE NO.12B
CARBON STEEL BLADE NO.21
CARBON STEEL BLADE NO.15C
CARBON STEEL BLADE NO.15
CARBON STEEL BLADE NO.12B
STAINLESS STEEL BLADE NO.21
STAINLESS STEEL BLADE NO.22
STAINLESS STEEL BLADE NO.20
CARBON STEEL BLADE NO.20
CryotopUS
SHORT HANDLED BIOPSY PUNCH 4MM
SHORT HANDLED BIOPSY PUNCH 3.5MM
SHORT HANDLED BIOPSY PUNCH 6MM
SHORT HANDLED BIOPSY PUNCH 5MM
Kitazato OPU Needle with Connection Tube, model number Type 2
Kitazato OPU Reduced Needle, model number Type 3
CryotopSC
PENTAX Single Use Balloon OE-A52
SUCTION VALVE
Kitazato IUI Catheter with Stainless Steel Center Core Type, 7 cm, model number Type 1-v2
Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, model number Type 2-v2
Kitazato IUI Catheter with Stainless Steel Center Core Type, 10 cm, model number Type 1-v1
Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1
MAJ-1555
Maeda Silver Acupuncture Needle
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)