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Singapore HSA registration DE0505515

OCULUS Pentacam®

Singapore flagSingapore·CLASS B·OCULUS Optikgeräte GmbH·Registered March 01, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0505515
Registration Date
March 01, 2021
Retention Due Date
February 28, 2026
Product description
The Pentacam® AXL and Pentacam® AXL Wave are designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - Corneal shape, - Analyze condition of the lens (opaque crystalline lens), - Analyze the anterior chamber angle, - Analyze anterior chamber depth, - Analyze the volume of the anterior chamber, - Analyze anterior or posterior cortical opacity, - Analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, - Corneal thickness, - Axial length, - White-to-white distance, - Optical aberrations of the eye (Pentacam® AXL Wave only), - Retroillumination imaging (Pentacam® AXL Wave only). Both models also perform calculations to assist physicians in determining the power of the intraocular lens for implantation.
Product Owner
Name
OCULUS Optikgeräte GmbH
Short Name
OCULUS Optikgeräte GmbH
Address
Dutenhofen, Münchholzhäuser Straße 29, 35582 Wetzlar, GERMANY
Registrant
Name
Surgipro Pte Ltd
Address
23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Importer
Name
Surgipro Pte Ltd
Address
23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Model information
Model Name(s)
Pentacam® AXL Wave Pentacam® AXL Floating License Key
Model Identifier(s)
70020 70100 77900
About this record

Access comprehensive regulatory information for OCULUS Pentacam® in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505515 and owned by OCULUS Optikgeräte GmbH. The device was registered on March 01, 2021.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B