Singapore HSA registration DE0500538

MANI, INC. MANI OPHTHALMIC KNIFE

Singapore·CLASS B·MANI, INC.·Registered May 25, 2017

Device classification

Device Class: CLASS B
Medical Speciality Area: Ophthalmology

Registration information

Registration Number: DE0500538
Registration Date: May 25, 2017
Change Notification Approval Date: July 05, 2022
Retention Due Date: May 24, 2025

Product description

This knife is to be used to incise and penetrate into eyeballs.

Product Owner

Name: MANI, INC.
Short Name: MANI, INC.
Address: 8-3 Kiyohara Industrial Park,, Utsunomiya,, Tochigi 321-3231, JAPAN

Registrant

Name: Transmedic Pte Ltd
Address: 5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349

Importer

Name: SWISSMED PTE LTD TRANSMEDIC PTE LTD
Address: 2 KALLANG AVENUE, CT HUB, #09-19, SINGAPORE 339407 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349

Model information

Model Name(s): MANI Ophthalmic Knife, Crescent Double Bevel 1.0mm MANI Ophthlamic Knife, Crescent Double Bevel 1.25mm MANI Ophthalmic Knife, Crescent Bevel Down 2.3mm MANI Ophthalmic Knife, Crescent Straight 2.3mm MANI Ophthalmic Knife, Crescent Bevel Up 2.0mm MANI Ophthalmic Knife, Crescent Bevel Up 2.0mm (Short-Head) MANI Ophthalmic Knife, Crescent Bevel Up 2.0mm (Safety) MANI Ophthalmic Knife, Crescent Bevel Up 2.3mm MANI Ophthalmic Knife, Crescent Bevel Up 2.3mm (Short-Head) MANI Ophthalmic Knife, Crescent Bevel Up 2.3mm (Safety) MANI Ophthalmic Knife, Depth 300μ(0.30mm) MANI Ophthalmic Knife, Depth 350μ(0.35mm) MANI Ophthlamic Knife, Golf/Scleral Knife MANI Ophthalmic Knife, LRI 500μ (0.50mm) MANI Ophthalmic Knife, LRI 550μ (0.55mm) MANI Ophthalmic Knife, LRI 600μ (0.60mm) MANI Ophthalmic Knife, LRI 650μ (0.65mm) MANI Ophthalmic Knife, Port Knife 25G MANI Ophthalmic Knife, Port Knife 27G MANI Ophthalmic Knife, R Slit Angled 2.6mm MANI Ophthalmic Knife, R Slit Angled 3.2mm MANI Ophthalmic Knife, R Slit Angled 3.5mm MANI Ophthalmic Knife, R Slit Angled 3.75mm MANI Ophthalmic Knife, R Slit Angled 4.1mm MANI Ophthalmic Knife, R Slit Angled 5.2mm MANI Ophthalmic Knife, R Slit Angled 5.5mm MANI Ophthalmic Knife, Slit angled 1.0mm MANI Ophthalmic Knife, Slit angled 1.0mm (Safety) MANI Ophthalmic Knife, Slit angled 1.1mm MANI Ophthalmic Knife, Slit angled 1.2mm MANI Ophthalmic Knife, Slit angled 1.2mm (Safety) MANI Ophthalmic Knife, Slit angled 1.3mm MANI Ophthalmic Knife, Slit angled 1.4mm MANI Ophthalmic Knife, Slit angled 1.4mm (Safety) MANI Ophthalmic Knife, Slit angled 1.6mm MANI Ophthalmic Knife, Slit angled 1.8mm MANI Ophthalmic Knife, Slit angled 1.8mm Arched MANI Ophthalmic Knife, Slit angled 1.8mm (Safety) MANI Ophthalmic Knife, Slit angled 1.9mm MANI Ophthalmic Knife, Slit angled 20.mm MANI Ophthalmic Knife, Slit angled 2.0mm Arched MANI Ophthalmic Knife, Slit angled 20.mm (Short-Head) MANI Ophthalmic Knife, Slit angled 20.mm (Safety) MANI Ophthalmic Knife, Slit angled 2.1mm MANI Ophthalmic Knife, Slit angled 2.1mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.2mm MANI Ophthalmic Knife, Slit angled 2.2mm Arched MANI Ophthalmic Knife, Slit angled 2.2mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.2mm (Safety) MANI Ophthalmic Knife, Slit angled 2.3mm MANI Ophthalmic Knife, Slit angled 2.3mm Arched MANI Ophthalmic Knife, Slit angled 2.3mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.3mm (Safety) MANI Ophthalmic Knife, Slit angled 2.4mm MANI Ophthalmic Knife, Slit angled 2.4mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.4mm (Safety) MANI Ophthalmic Knife, Slit angled 2.5mm MANI Ophthalmic Knife, Slit angled 2.5mm Arched MANI Ophthalmic Knife, Slit angled 2.5mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.5mm (Safety) MANI Ophthalmic Knife, Slit angled 2.65mm MANI Ophthalmic Knife, Slit angled 2.65mm Arched MANI Ophthalmic Knife, Slit angled 2.65mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.65mm (Safety) MANI Ophthalmic Knife, Slit angled 2.75mm MANI Ophthalmic Knife, Slit angled 2.75mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.75mm (Safety) MANI Ophthalmic Knife, Slit angled 2.8mm MANI Ophthalmic Knife, Slit angled 2.8mm Arched MANI Ophthalmic Knife, Slit angled 2.8mm (Short-Head) MANI Ophthalmic Knife, Slit angled 2.8mm (Safety) MANI Ophthalmic Knife, Slit angled 2.9mm MANI Ophthalmic Knife, Slit angled 2.9mm Arched MANI Ophthalmic Knife, Slit angled 2.9mm (Short-Head) MANI Ophthalmic Knife, Slit angled 3.0mm MANI Ophthalmic Knife, Slit angled 3.0mm Arched MANI Ophthalmic Knife, Slit angled 3.0mm (Short-Head) MANI Ophthalmic Knife, Slit angled 3.0mm (Safety) MANI Ophthalmic Knife, Slit angled 3.2mm MANI Ophthalmic Knife, Slit angled 3.2mm Arched MANI Ophthalmic Knife, Slit angled 3.2mm (Safety) MANI Ophthalmic Knife, Slit angled 3.4mm Arched MANI Ophthalmic Knife, Slit angled 3.5mm MANI Ophthalmic Knife, Side Port 45 degree Angled 1.0mm MANI Ophthalmic Knife, Side Port 30 degree Angled 1.0mm MANI Ophthalmic Knife, Slit straight 1.0mm MANI Ophthalmic Knife, Slit straight 2.8mm MANI Ophthalmic Knife, Slit angled 3.0mm MANI Ophthalmic Knife, Straight 0° MANI Ophthalmic Knife, Straight 15° MANI Ophthalmic Knife, Straight 15°(Marking) MANI Ophthalmic Knife, Straight 15°(Safety) MANI Ophthalmic Knife, Straight 22.5° MANI Ophthalmic Knife, Straight 22.5°(Marking) MANI Ophthalmic Knife, Straight 22.5°(Safety) MANI Ophthalmic Knife, Straight 30° MANI Ophthalmic Knife, Straight 30°(Safety) MANI Ophthalmic Knife, Straight 45° MANI Ophthalmic Knife, MVR-Lance 19G MANI Ophthalmic Knife, MVR-Angled 19G MANI Ophthalmic Knife, MVR-Lance 20G MANI Ophthalmic Knife, MVR-Angled 20G MANI Ophthalmic Knife, MVR-Angled 20G (Safety) MANI Ophthalmic Knife, MVR-Angled 21G MANI Ophthalmic Knife, MVR-Angled 21G (Safety) MANI Ophthalmic Knif,e MVR-Lance 23G MANI Ophthalmic Knife, MVR-Angled 23G MANI Ophthalmic Knife, MVR-Angled 23G MANI Ophthalmic Knife, MVR-Angled 23G (Safety) MANI Ophthalmic Knife, MVR-Lance 24G MANI Ophthalmic Knife, MVR-Angled 24G MANI Ophthalmic Knife, MVR-Angled 24G (Safety) MANI Ophthalmic Knife, MVR-Lance 25G
Model Identifier(s): MCB10 MCB12 MCD26 MCS26 MCU20 MCU20SH MCU20SK MCU26 MCU26SH MCU26SK MDP30 MDP35 MGL24 MLR50 MLR55 MLR60 MLR65 MPK25 MPK27 MRS26 MRS32 MRS35 MRS37 MRS41 MRS52 MRS55 MSL10 MSL10SK MSL11 MSL12 MSL12SK MSL13 MSL14 MSL14SK MSL16 MSL18 MSL18AB MSL18SK MSL19 MSL20 MSL20AB MSL20SH MSL20SK MSL21 MSL21SH MSL22 MSL22AB MSL22SH MSL22SK MSL23 MSL23AB MSL23SH MSL23SK MSL24 MSL24SH MSL24SK MSL25 MSL25AB MSL25SH MSL25SK MSL26 MSL26AB MSL26SH MSL26SK MSL27 MSL27SH MSL27SK MSL28 MSL28AB MSL28SH MSL28SK MSL29 MSL29AB MSL29SH MSL30 MSL30AB MSL30SH MSL30SK MSL32 MSL32AB MSL32SK MSL34AB MSL35 MSP10 MSP10L MSS10 MSS28 MSS30 MST00 MST15 MST15MK MST15SK MST22 MST22MK MST22SK MST30 MST30SK MST45 MVR19 MVR19A MVR20 MVR20A MVR20ASK MVR21A MVR21ASK MVR23 MVR23A MVR23AD MVR23ASK MVR24 MVR24A MVR24ASK MVR25

About this record

Access comprehensive regulatory information for MANI, INC. MANI OPHTHALMIC KNIFE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500538 and owned by MANI, INC.. The device was registered on May 25, 2017.

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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