FDA Registration
Active
🇻🇳 Vietnam
ASAHI INTECC HANOI CO., LTD.
Reg #: 3009121749
·
FEI: 3009121749
·
Expires 2026
Products
5
Proprietary Names
136
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ASAHI INTECC HANOI CO., LTD.
- Registration Number
- 3009121749
- FEI Number
- 3009121749
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot G-3, Thang Long Industrial Park, Thien Loc Commune,
- City
- Hanoi Ha Noi
- Country
- VN
Owner / Operator
- Firm Name
- ASAHI INTECC CO., LTD.
- Operator Number
- 9051916
- Address
- 3-100 Akatsuki-cho, --
- City
- Seto
- State
- Aichi
- Postal Code
- 489-0071
- Country
- JP
US Agent
- Business Name
- ASAHI INTECC CO., LTD.
- Contact Name
- Ariel Barrett
- Address
- 22 Executive Park, Suite 110
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
- [email protected]
- Phone
- 949 7568636
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2016-08-26 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2021-12-08 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2011-12-19 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2024-12-23 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2023-07-28 |
Proprietary Names
ASAHI Corsair Pro 150cm
ASAHI Corsair Pro 135cm
CONFIANZA PRO 8-20
Fielder J
CHIKAI
CONFIANZA PRO
ULTIMATEbros
ASAHI Silverway
ASAHI Gladius
ASAHI Halberd
ASAHI Gaia PV
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
ASAHI Fielder XT-A
ASAHI Fielder XT-A 300cm
ASAHI Fielder XT-R
ASAHI Fielder XT-R 300cm
Treasure Floppy
Astato XS 20
Regalia XS
Astato XS 40
ASAHI PTCA Guide Wire ASAHI SION black
CHIKAI Nexus petit
Miracle 6
Miraclebros 6
Rinato
Miraclebros 3
Prowater
Grand Slam
Asahi Soft
Miracle 3
ASAHI Gaia
Fielder FC
ASAHI Meister 16 165cm ANGLED DOUBLE
ASAHI Meister 16 180cm ANGLED 45degree
ASAHI Meister 16 135cm ANGLED DOUBLE
ASAHI Meister 16 165cm Round curve Re- Shapable
ASAHI Meister 16 165cm ANGLED 45degree
ASAHI Meister 16 180cm ANGLED DOUBLE
ASAHI Meister 16 180cm Round curve Re- Shapable
ASAHI Meister 16 135cm Round curve Re-Shapable
ASAHI Meister 16 135cm ANGLED 45degree
CHIKAI Round Curve
CHIKAI Nexus 014
ASAHI RG3 Soft
ASAHI RG3
ASAHI SION blue
ASAHI SUOH 03
Treasure
ASAHI Caravel
ASAHI CHIKAI black 14 soft tip
Miracle bros
Confianza Pro
ASAHI CHIKAI black 18 soft tip
ASAHI Neurovascular Guide Wire ASAHI CHIKAI black
ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008
ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18
ASAHI CHIKAI X 010
CHIKAI V
ASAHI SION
Prowater J
Prowaterflex J
Grand Slam J
Confianza Pro J
Miraclebros J
Asahi Soft J
Routreme J
Tornus ES
Gladius Mongo 14
Gladius Mongo 14 ES
Astato 30
PROWATER
ASAHI Gladius18
MIRACLEBROS 3
Treasure 12
MIRACLEBROS 6
ASAHI Gaia First
ULTIMATEbros 3
ASAHI Gaia PV18
PROWATERflex
FIELDER
FIELDER XT
SOFT
GRAND SLAM
CONFIANZA PRO 12
MIRACLEBROS 12
ASAHI Gaia Third
EXTENSION
FIELDER XT-A
ASAHI Gaia Second
FIELDER FC
Astato XS40
Regalia XS 1
FIELDER XT-R
Halberd18
ASAHI CROSSWALK Peripheral Support Catheter
SION
CROSSLOOP
Miraclebros
Fielder
ASAHI Gaia First 300cm
ASAHI Gaia Second Pre- shape
ASAHI Gaia Second 300cm
ASAHI Gaia Third 300cm
ASAHI MIRACLEbros 6 300cm
ASAHI ULTIMATEbros 3 180cm J
ASAHI CONFIANZA PRO 12 180cm
ASAHI MIRACLEbros 4.5 180cm
ASAHI MIRACLEbros 6 180cm
ASAHI FIELDER XT-A 300cm
ASAHI MIRACLEbros 12 180cm
ASAHI MIRACLEbros 3 180cm
ASAHI Gaia Third Pre- shape
ASAHI ULTIMATEbros 3 180cm
ASAHI Gaia First 300cm Pre-shape
ASAHI CONFIANZA PRO 300cm
ASAHI Gaia Second 300cm Pre-shape
ASAHI Gaia Third 300cm Pre-shape
ASAHI Corsair Pro, 150cm
ASAHI CONFIANZA PRO 12 300cm
ASAHI Corsair Pro, 135cm
ASAHI ULTIMATEbros 3 300cm
ASAHI FIELDER XT-A 190cm
ASAHI MIRACLEbros 12 300cm
ASAHI FIELDER XT-R 300cm
ASAHI FIELDER XT 190cm
ASAHI Gaia First Pre- shape
ASAHI FIELDER XT-R 190cm
ASAHI MIRACLEbros 3 300cm
ASAHI MIRACLEbros 4.5 300cm
ASAHI CONFIANZA PRO 180cm
ASAHI ULTIMATEbros 3 300cm J
ASAHI FIELDER XT 300cm
X-treme
Prowaterflex
Routreme
Fielder 18 Endoscopic Guide Wire
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)