Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036795697

FEI Number

3036795697

Entity Name

KAIZEN DYNAMIC LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

UNIT A 5/F MAX SHARE CENTER 373 KING'S ROAD NORTH POINT, Hong Kong 999077, HK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kaizen Dynamic Limited (Owner Number: 10092914)

Owner / Operator Contact Address

UNIT A 5/F MAX SHARE CENTER 373 KING'S ROAD NORTH POINT, Hong Kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IBT-SK2-30B CHN-REFILL-30-1 N-AMZ-REFILL-30 CHN-SK-30W-1 IBT-START-15C N-REFILL-PLAN AMZ-SK2-15C N-AMZ-REFILL-60 CHN-SK-15B-1 N-OFF-REFILL-60 CHN-SK-15W-1 IBT-SK2-15B IBT-START-30C N-OFF-REFILL-90 N-AMZ-REFILL-90 AMZ-SK2-15B CHN-SK-30B-1 AMZ-SK2-30B AMZ-SK2-30C N-OFF-REFILL-30

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2025-03-06
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2025-12-05

Official Correspondent

Doris Liu

US Agent Details

Mike Ryan Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

Kaizen Dynamic 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 3036795697. Last updated year: 2026. Please use registration number 3036795697 when referencing this establishment in official correspondence.