Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042471321

FEI Number

3042471321

Entity Name

YIXIN PRECISION ENGINEERING PTE LTD

City/State/Country

SINGAPORE Central Singapore, SG

Establishment Address

20 WOODLANDS LINK, #02-22 WOODLANDS EAST INDUSTRIAL ESTATE, SINGAPORE Central Singapore 738733, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

YIXIN PRECISION ENGINEERING PTE LTD (Owner Number: 10094721)

Owner / Operator Contact Address

20 WOODLANDS LINK, #02-22 WOODLANDS EAST INDUSTRIAL ESTATE, SINGAPORE, SG-NOTA 738733, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile Single-Use BIPDDSC Bipolar Disc Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2025-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 2545756

Related Public Records

Same Entity

YIXIN PRECISION ENGINEERING 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
K961841	C.R. Bard, Inc.	BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)	1996-10-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042471321. Last updated year: 2026. Please use registration number 3042471321 when referencing this establishment in official correspondence.