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Stryker Endoscopy Advanced Imaging Modality (AIM) System - HSA Registration DE0501172

Access comprehensive regulatory information for Stryker Endoscopy Advanced Imaging Modality (AIM) System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501172 and owned by Stryker Endoscopy. The device was registered on January 31, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0501172
Stryker Endoscopy Advanced Imaging Modality (AIM) System
HSA Registration Number: DE0501172
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Product Description

Stryker Endoscopy Advanced Imaging Modality (AIM) System is an endoscopic camera system consisting of AIM Laparoscopes, AIM Camera Systems, AIM Light Sources and IRIS Ureteral kit to produce still and video images in the surgical field during surgical endoscopic procedures that clinicians deem appropriate for the patient. The AIM HD Autoclavable Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501172
Registration Date
January 31, 2018
Change Notification Approval Date
October 04, 2022
Retention Due Date
January 30, 2026
Product Owner
Short Name
Stryker
Address
5900 Optical Court, San Jose, CA 95138, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
IRIS Ureteral Kit Precision LED light Source L10 LED Light Source with AIM Technology AIM SafeLight Fiber Optic Cable AIM HD Laparoscope, Autoclavable AIM HD Laparoscope, Autoclavable AIM HD Laparoscope, Autoclavable AIM HD Laparoscope, Autoclavable 1588 AIM Camera Control Unit AIM Coupler, 18 mm, C--Mount 1588 AIM Camera Head, C-Mount 1588 Pendulum Camera Head with Integrated Coupler 1588 AIM Camera Head with Integrated Coupler 1588 AIM Inline Camera Head, C-Mount
Model Identifier(s)
0220180518 0220220000 0220220300 0233050300 0502537010 0502537030 0502937010 0502937030 1588010000 1588020122 1588210105 1588310130 1588610122 1588710105