Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012017650

FEI Number

3012017650

Entity Name

FOXXMED LTD

City/State/Country

Ilan Yilan, TW

Establishment Address

No.60, Jianjin 2nd Rd.,, Dongshan Township, Yilan County 269, Ilan Yilan 269, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FoxxMed Ltd (Owner Number: 10049944)

Owner / Operator Contact Address

No.60, Jianjin 2nd Rd.,, Dongshan Township, Yilan County 269, Ilan, TW-ILA 269, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

"TendMIN" Grasper TendMIN Telescope Needle Ories Cohesive Bandage Stoma Cushion HEADGEAR High Flow Nasal Cannula OXYGEN MASK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-09-05
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-09-24
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2026-04-29
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2017-09-06
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-04-29
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2015-09-09
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2017-11-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2017-11-21

Official Correspondent

Will Chen

US Agent Details

Joseph Consoli Business: Sunset Healthcare Solutions, Inc. Email: jconsoli@sunsethcs.com Phone: (847) 3802824

Related Public Records

Same Entity

FoxxMed Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012017650. Last updated year: 2026. Please use registration number 3012017650 when referencing this establishment in official correspondence.