Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001169291

FEI Number

3001169291

Entity Name

DAANSEN TAIWAN INC.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

1-5 FONLIN ROAD, BARLI DIST., NEW TAIPEI CITY 249, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DAANSEN TAIWAN INC. (Owner Number: 10089421)

Owner / Operator Contact Address

1-5 FONLIN ROAD, BARLI DIST., NEW TAIPEI CITY, TW-NWT 249, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POCKET PAL HOLD DEVICE HEMOBILIZER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-12-06
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-12-06

Official Correspondent

Brenda Yu

US Agent Details

Paul Kurth Business: Pressure Products Medical Supplies Inc. Email: paul@pressure-products.com Phone: (805) 6370715

Related Public Records

Same Entity

DAANSEN TAIWAN INC.

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 3001169291. Last updated year: 2026. Please use registration number 3001169291 when referencing this establishment in official correspondence.