Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025376090

FEI Number

3025376090

Entity Name

Bothwin (Beijing) Medical Technology Co., Ltd.

City/State/Country

Beijng Beijing, CN

Establishment Address

1st-4th floor, No.32 Building, 401-06 to 401-13, 4th floor, No.33 Building, No.20 Yard, Changheng Road,, Beijing Economic-Technological Development Area (Daxing), Beijing, P.R. China, Beijng Beijing 102615, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bothwin (Beijing) Medical Technology Co., Ltd. (Owner Number: 10085916)

Owner / Operator Contact Address

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Binocular Loupes Bile Duct Dilators Micro Clamps Clip Applier Scissors Medical Scissors Micro Scissors Accessories:010101/010201/010202/010301/010302/010501/010601/010602/010701 Tissue Position/Stabilizing Devices( 02-0302B/02-011B/ 02-013A/02-013C/02-014/02-015/ 02-016) Tissue Position/Stabilizing Devices(02-0101/02-0103/02-0201/02-0203A/02-0203B/02-0300B/02-0301) Tissue Position/Stabilizing Devices( 02-017/02-023/02-024) Hemostatic Forceps Suction Tubes Needle holders Micro-needle holders Vascular Punches Knife Handles Dissector Silicone Loops Suture Guides Cardiac Sump Coronary Scalpels Bone Bitting Rongeurs Retractors Heart Retractors Abdominal Retractors Tissue Hooks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2022-12-27
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2022-12-27
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2022-12-27
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-12-27
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-12-27
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2022-10-27
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-11-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-12-27
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2022-12-27
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-11-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-12-27
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-27
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-08-21
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-08-21
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2026-03-05
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-08-21
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2022-12-27
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-11-02

Official Correspondent

Hongxiao Liu

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Bothwin (Beijing) Medical Technology Co., Ltd.

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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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3009768364	Foshan CICADA Dental Instrument Co., Ltd.	Foshan Guangdong, CN
3005515469	DENTLIGHT INC.	Plano, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025376090. Last updated year: 2026. Please use registration number 3025376090 when referencing this establishment in official correspondence.