Toyoflex Cebu Corporation

FDA Device Registration & Listing · Lapu-Lapu Cebu, PH · Registration 3016119728

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016119728
FEI Number
3016119728
Entity Name
Toyoflex Cebu Corporation
City/State/Country
Lapu-Lapu Cebu, PH
Establishment Address
Lot14, Block2, Cebu Light Industrial Park (CLIP), Basak, Lapu-Lapu Cebu 6015, PH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ASAHI INTECC CO., LTD. (Owner Number: 9051916)
Owner / Operator Contact Address
3-100 Akatsuki-cho, --, Seto, JP-23 489-0071, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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 Miracle bros Confianza Pro X-treme Fielder ASAHI Gladius ASAHI Halberd ASAHI Gaia PV ASAHI SION blue SION ASAHI SION CHIKAI V ASAHI Fielder XT-A ASAHI Fielder XT-A 300cm ASAHI Fielder XT-R ASAHI Fielder XT-R 300cm Regalia XS Gladius Mongo 14 Gladius Mongo 14 ES Fielder CHIKAI Prowater J Prowaterflex J Grand Slam J Confianza Pro J Miraclebros J Asahi Soft J Routreme J Fielder J Fielder FC ASAHI PTCA Guide Wire ASAHI SION black Fielder FC CHIKAI Round Curve

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-10-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-03-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-07-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-08-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-08-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-06-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-01-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-07-19
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-14
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2011-08-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-07-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-14
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2016-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

Ariel Barrett Business: ASAHI INTECC CO., LTD. Email: ariel.barrett@asahi-intecc-us.com Phone: (949) 7568636

Related Public Records

Same Entity

ASAHI INTECC CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004718255 ASAHI INTECC USA, INC. Tustin, CA, US
3003780911 ASAHI INTECC (THAILAND) CO., LTD. Amphur Muang Pathumthani Pathum Thani, TH
3009121749 ASAHI INTECC HANOI CO., LTD. Hanoi Ha Noi, VN
3003775027 ASAHI INTECC CO., LTD. SETO Aichi, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016119728. Last updated year: 2026. Please use registration number 3016119728 when referencing this establishment in official correspondence.
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