Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016068274

FEI Number

3016068274

Entity Name

3H APOTHEKE LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Unit 1132, 11/F, Liven House, 61-63 King Yip Street, Kwun Tong, Kowloon, Hong Kong 999077, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

3H Apotheke Limited (Owner Number: 10062037)

Owner / Operator Contact Address

Flat/Rm 04C35 9F Sunbeam Centre 27, Shing Yip Street, Kwun Tong, HK-NOTA -, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KIT, SURGICAL INSTRUMENT, DISPOSABLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2024-04-17
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2024-04-17
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2024-04-17
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2024-04-17
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2024-08-02
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2025-12-19
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-04-17
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2022-03-02
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-04-17
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-09-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-12-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-11-30

Official Correspondent

Zhu Zhiyang

US Agent Details

Dale Li Business: HTT TECHNOLOGIES INC. Email: emily.zhang@3hmedical.com Phone: (954) 2785450

Related Public Records

Same Entity

3H Apotheke Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue
Z-0037-2007	Medline Industries Inc	2	Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue

Similar Registrations

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8043549	HMS-VILGO	BERGERAC, CEDEX Dordogne, FR
3017491621	A Better Walker, LLC	Loveland, CO, US
1641302	ALEX ORTHOPEDIC, INC.	GRAND PRAIRIE, TX, US
3008771621	Valmar Surgical Supplies, Inc.	Lakewood, NJ, US
3014273557	CC HSING COMPANY LIMITED	Xikou Township Chiayi, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016068274. Last updated year: 2026. Please use registration number 3016068274 when referencing this establishment in official correspondence.