Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042172872

FEI Number

3042172872

Entity Name

BOTHWIN MEDICAL TECHNOLOGY (SG) PTE. LTD.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

77 SCIENCE PARK DRIVE, #04-10, CINTECH III BUILDING, SINGAPORE, Singapore Central Singapore 118256, SG

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BOTHWIN MEDICAL TECHNOLOGY (SG) PTE. LTD. (Owner Number: 10094035)

Owner / Operator Contact Address

77 SCIENCE PARK DRIVE, #04-10, CINTECH III BUILDING, SINGAPORE, Singapore, SG-01 118256, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Negative Pressure Regulator Binocular Loupes Bone Bitting Rongeurs Medical Headlight Scalpels Dissector Tissue Position/Stabilizing Devices Wire Cutter Silicone Loops Blowers/Misters Clip Applier Vascular Punches Hemostatic Forceps Micro Vascular Clamps Coronary Scalpels Needle Holders Micro-needle Holders Tissue Forceps Micro Tissue Forceps Instrument Forceps Towel Forceps Scissors Micro Scissors Abdominal Retractors Forceps Shaped Retractors Spreaders Suture Guides Bile Duct Dilators Skin Tissue Punches Cardiac Sump Knife Handles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2025-11-30
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-30
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2025-11-30
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2025-11-30
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-01
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-11-30
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2025-11-30
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2025-11-30
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-01
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-11-30
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2025-11-30
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-12-01
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2025-11-30
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-01
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2025-11-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-11-30
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-11-30
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-12-01
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2025-11-30
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-30
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2026-03-05
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-11-30

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 MEDICAL TECHNOLOGY (SG) PTE. 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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3006897996	HOSPITAL & HOMECARE IMP. & EXP. CO., LTD	NANJING Jiangsu, CN
3007360714	HERSILL, S.L.	MOSTOLES (MADRID) Madrid (Province), ES
2523148	PRECISION MEDICAL, INC.	NORTHAMPTON, PA, US
3006395447	ACARE TECHNOLOGY CO., LTD.	New Taipei City, TW
2221819	MINDRAY DS USA, Inc.	Mahwah, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042172872. Last updated year: 2026. Please use registration number 3042172872 when referencing this establishment in official correspondence.