Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004646509

FEI Number

3004646509

Entity Name

REGAL PROSTHESIS LIMITED

City/State/Country

Kwai Chung NT, HK

Establishment Address

Room 3D Mai Luen Industrial Building, 23-31 Kung Yip Street, Kwai Chung NT -, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

REGAL PROSTHESIS LIMITED (Owner Number: 9083320)

Owner / Operator Contact Address

Room 3D Mai Luen Industrial Building, 23-31 Kung Yip Street, Kwai Chung NT, HK-NOTA -, HK

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
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2016-08-30
NOK	Material, External Aesthetic Restoration, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2020-07-29
ISL	Joint, Hip, External Limb Component	Physical Medicine	Class 1	890.3420	2016-08-30
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2016-08-30

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

REGAL PROSTHESIS LIMITED

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 3004646509. Last updated year: 2026. Please use registration number 3004646509 when referencing this establishment in official correspondence.