Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025347444

FEI Number

3025347444

Entity Name

SML MED-TECH SOLUTIONS LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Unit 406, Wah Yiu Industrial Centre, 30-32 Au Pui Wan Street, Fo Tan, N.T., Hong Kong 000000, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SML Med-Tech Solutions Limited (Owner Number: 10086535)

Owner / Operator Contact Address

Unit 406, Wah Yiu Industrial Centre, 30-32 Au Pui Wan Street, Fo Tan, N.T., Hong Kong, HK-NOTA 000000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Endoscope Valve Sets Disposable Endoscope Valve Sets (SML002-LP01) Disposable Protective Liner- Cerofrict Disposable Polyp Trap- Cerofrict Disposable Endoscope Tip Protector- Cerofrict Disposable Bite Block- Cerofrict Air Water Channel Cleaning Adapter- Cerofrict

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2023-01-28
PHT	Basin For Endoscope Reprocessing	Gastroenterology, Urology	Class 1	876.1500	2022-11-17
CBC	Bottle, Collection And Trap, Breathing System (Uncalibrated)	General Hospital	Class 2	880.6740	2022-11-17
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-11-17
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2022-11-17
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-11-17

Official Correspondent

TSZ HANG Ko

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

SML Med-Tech Solutions 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 3025347444. Last updated year: 2026. Please use registration number 3025347444 when referencing this establishment in official correspondence.