Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003855981

FEI Number

3003855981

Entity Name

ACOT PLASTICS (XIAMEN) CO., LTD.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

No.89 Zhaogang East Road, Xiangan, XIAMEN Fujian 361101, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ACOT PLASTICS (XIAMEN) CO., LTD. (Owner Number: 9063936)

Owner / Operator Contact Address

No.89 Zhaogang East Road,Xiangan, XIAMEN, CN-FJ 361101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Seal- Tight Safe-Tips EZ External Ankle/Joint Brace Dental Nozzle AFO1 Swift System AFO1 FreeFlow Wrist Splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2021-08-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2010-06-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2009-10-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2004-06-03
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2010-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

ACOT PLASTICS (XIAMEN) 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 3003855981. Last updated year: 2026. Please use registration number 3003855981 when referencing this establishment in official correspondence.