Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016950436

FEI Number

3016950436

Entity Name

TIANCK MEDICAL CO.,LTD

City/State/Country

Huizhou Guangdong, CN

Establishment Address

Building No.7, Wandong Zhigu industry park, Jiangjun East Road, Huiyang District, Huizhou Guangdong 516213, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TIANCK MEDICAL CO.,LTD (Owner Number: 10083485)

Owner / Operator Contact Address

Building C, No.16 Yinkui road, Kuichong town, Dapeng new district, Shenzhen, CN-GD 518119, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-vascular introducer system IV cannula Guidewire Syring Radial artery closure band Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-08-08
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2022-12-29
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-23
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2021-11-23
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-12-10

Official Correspondent

Jingyu Sun

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

TIANCK MEDICAL CO.,LTD

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016950436. Last updated year: 2026. Please use registration number 3016950436 when referencing this establishment in official correspondence.