Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009980711

FEI Number

3009980711

Entity Name

SIGMAX(HUZHOU)MEDICAL.CO.,LTD.

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

Xiangyi Industrial Park, Southwest district, Huzhou Zhejiang 313000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SIGMAX (HUZHOU) MEDICAL.CO.,LTD. (Owner Number: 10043538)

Owner / Operator Contact Address

Xiangyi Industrial Park, Southwest district, Huzhou, CN-ZJ 313000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2013-02-25
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-06-28

Official Correspondent

Kenneth Block

US Agent Details

Kenneth L Block Business: Ken Block Consulting Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

SIGMAX (HUZHOU) MEDICAL.CO.,LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009980711. Last updated year: 2026. Please use registration number 3009980711 when referencing this establishment in official correspondence.