SG ENDOSCOPY PTE LTD

FDA Device Registration & Listing · Singapore North East, SG · Registration 3038613058

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038613058
FEI Number
3038613058
Entity Name
SG ENDOSCOPY PTE LTD
City/State/Country
Singapore North East, SG
Establishment Address
77 Loyang Way, Singapore North East 508765, SG
Establishment Type(s)
Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
SG Endoscopy Pte Ltd (Owner Number: 10093585)
Owner / Operator Contact Address
77 Loyang Way, Singapore, SG-02 508765, SG
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Cleaning Brush, Luer Port Single Luer Stopcock (pack of 2) Cleaning Brush, External F88 Flexible Ureteroscope, Reverse Deflection F88 Flexible Ureteroscope, Standard Deflection F88 Flexible Camera Control Unit (CCU) Cleaning Brush, Working Channel, Ureteroscope Vent Cap Manual Leak Tester

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-06-06

Official Correspondent

No official correspondent registered.

US Agent Details

David David Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SG Endoscopy 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
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038613058. Last updated year: 2026. Please use registration number 3038613058 when referencing this establishment in official correspondence.
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