Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038165043

FEI Number

3038165043

Entity Name

ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Zylox-Tonbridge Industrial Park, No. 270 Shuyun Road, Yuhang District, Hangzhou, Zhejiang Province, China., Hangzhou Zhejiang 311121, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zylox-Tonbridge Medical Technology Co., Ltd. (Owner Number: 10094673)

Owner / Operator Contact Address

Zylox-Tonbridge Industrial Park, No. 270 Shuyun Road, Yuhang District, Hangzhou, Zhejiang Province, China., Hangzhou, CN-ZJ 311121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212047

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2025-12-16
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2025-12-16
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2025-12-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2025-12-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2025-12-16
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2025-12-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2025-12-16
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2025-12-16

Official Correspondent

Wenner Xie

US Agent Details

Qihui Zhang Email: qzhang@zyppel.com Phone: (617) 2991655

Related Public Records

Same Entity

Zylox-Tonbridge Medical Technology Co., 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
K183320	St. Jude Medical (Now Abbott Medical)	Ilumien Optis, Optis Integrated, Optis Mobile	2019-04-02
K253459	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
K210458	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	2021-06-08
K071227	Spectranetics Corp.	CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15	2007-07-11

Similar Registrations

Registration Number	Establishment Name	Location
3042929028	OPXION TECH. INCORPORATION	Linkou Dist New Taipei, TW
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3042970803	LEADOPTIK INC.	San Jose, CA, US
3012179728	St. Jude Medical	Roseville, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038165043. Last updated year: 2026. Please use registration number 3038165043 when referencing this establishment in official correspondence.