FDA Registration
Active
🇯🇵 Japan
FMD. Co., Ltd.
Reg #: 3013023134
·
FEI: 3013023134
·
Expires 2026
Products
1
Proprietary Names
22
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- FMD. Co., Ltd.
- Registration Number
- 3013023134
- FEI Number
- 3013023134
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1-166 Shimoobari Nakashima
- City
- Komaki Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K151840
Owner / Operator
- Firm Name
- FMD Co., Ltd.
- Operator Number
- 10052039
- Address
- Sasazuka Daiichi Bldg. 8F, 1-57-7 Sasazuka, Shibuya-ku
- City
- Tokyo
- State
- JP-13
- Postal Code
- 151-0073
- Country
- JP
- Correspondent
- Mayumi Ito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-06-13 |
Proprietary Names
Marvel Guidewire
Fighter Guidewire
Stretch Extension Wire
Samurai RC Guidewire
Samurai Guidewire
JUDO 3 Guidewire
JUDO 1 Guidewire
JUDO 6 Guidewire
Hornet Guidewire
Hornet 10 Guidewire
Hornet 14 Guidewire
FMD Peripheral Guidewire F-14 Light
FMD Peripheral Guidewire F-18 Flex
FMD Peripheral Guidewire F-14 Tapered3
FMD Peripheral Guidewire F-14 Tapered15
FMD Peripheral Guidewire F-18 Hard15
FMD Peripheral Guidewire F-14 EXT
FMD Peripheral Guidewire F-14 Tapered30
FMD Peripheral Guidewire F-18 Floppy
FMD Peripheral Guidewire F-14 Flex
FMD Peripheral Guidewire F-14 Gentle
FMD Peripheral Guide Wire F-18 Flex 400
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device