Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008016588

FEI Number

3008016588

Entity Name

ANJI SANFANG MEDICAL DEVICE CO., LTD.

City/State/Country

anji Zhejiang, CN

Establishment Address

kangsan industry park, anji Zhejiang 313300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Anji Sanfang Medical Device Co., Ltd. (Owner Number: 10085721)

Owner / Operator Contact Address

kangsan industry park, anji, CN-ZJ 313300, 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
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-07-26
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2022-07-26

Official Correspondent

Cheng Guoqiang

US Agent Details

Melanie Leibowitz Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

Related Public Records

Same Entity

Anji Sanfang Medical Device 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 3008016588. Last updated year: 2026. Please use registration number 3008016588 when referencing this establishment in official correspondence.