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MANI, INC.

Japan·JP-MF-000017860

Last updated June 8, 2026

Information

Country
Japan
Address
8-3, Kiyohara Industrial Park, Utsunomiya, Tochigi, Japan
Website
mani.inc
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Toshiharu Kamei
EUDAMED SRN
JP-MF-000017860
FDA FEI Number
—
DUNS Number
690622428

Catalogue (2255)

Page 2 of 46
DeviceModel / ReferenceRegistriesClassStatus
MANI Sutures PGA 403
FDA UDI
Class IIActive
MANI Ophthalmic Knife MSL23AB Slit-Angled 2.3mm Arched
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL21SH-02 Slit-Angled 2.1mm SH
FDA UDI
Class IActive
MANI Sutures PGA 303
FDA UDI
Class IIActive
Mani Engine Reamers 28mm #70
FDA UDI
Class IActive
Mani Pluggers 21mm #20
FDA UDI
Class IActive
NiTi H-FILES 25mm #15
FDA UDI
Class IActive
Mani Micro Files TypeK #15
FDA UDI
Class IActive
Mani Pluggers 25mm #15
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL29-02 Slit-Angled 2.9mm
FDA UDI
Class IActive
MANI Ophthalmic Knife MST00 Straight 0°
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL22AB-02 Slit-Angled 2.2mm Arched
FDA UDI
Class IActive
MANI Ophthalmic Knife MST22SK Straight 22.5°SK
FDA UDI
Class IActive
MANI Ophthalmic Knife MCB12 Crescent Double Bevel 1.25mm
FDA UDI
Class IActive
Mani Micro Files TypeK #10
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL30AB Slit-Angled 3.0mm Arched
FDA UDI
Class IActive
MANI Sutures PGA 502
FDA UDI
Class IIActive
MANI Ophthalmic Knife MLR50 Guard Knife LRI 500µm
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL34AB Slit-Angled 3.4mm Arched
FDA UDI
Class IActive
MANI Ophthalmic Knife MVR24ASK-02 MVR-Angled 24G SK
FDA UDI
Class IActive
MANI Sutures PGA 501
FDA UDI
Class IIActive
MANI Ophthalmic Knife MSL32SK Slit-Angled 3.2mm SK
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL30SK Slit-Angled 3.0mm SK
FDA UDI
Class IActive
MANI NiTi FLARE FILES 25mm #20
FDA UDI
Class IActive
Mani Micro Files TypeK #8
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL24SH Slit-Angled 2.4mm SH
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL12-02 Slit-Angled 1.2mm
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL19-02 Slit-Angled 1.9mm
FDA UDI
Class IActive
MANI Sutures PGA 3391
FDA UDI
Class IIActive
MANI Ophthalmic Knife MSL25SH-02 Slit-Angled 2.5mm SH
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL22 Slit-Angled 2.2mm
FDA UDI
Class IActive
MANI Ophthalmic Knife MSS10-02 Slit 1.0mm
FDA UDI
Class IActive
NiTi H-FILES 25mm #15-40
FDA UDI
Class IActive
Mani Engine Reamers 25mm #45-80
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL28AB-02 Slit-Angled 2.8mm Arched
FDA UDI
Class IActive
NiTi H-FILES 21mm #15
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL22SK Slit-Angled 2.2mm SK
FDA UDI
Class IActive
Mani Micro Files TypeK #20
FDA UDI
Class IActive
MANI Sutures PGA 302
FDA UDI
Class IIActive
Mani Disposable Vessel Knife FDVKE500
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL13 Slit-Angled 1.3mm
FDA UDI
Class IActive
MANI Sutures PGA 404
FDA UDI
Class IIActive
Mani Disposable Vessel Knife FDVKE101
FDA UDI
Class IActive
MANI Sutures PGA 2092
FDA UDI
Class IIActive
MANI Ophthalmic Knife MVR20-02 MVR-Lance 20G
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL28SK-02 Slit-Angled 2.8mm SK
FDA UDI
Class IActive
MANI Ophthalmic Knife MRS32-02 R Slit-Angled 3.2mm
FDA UDI
Class IActive
MANI Ophthalmic Knife MVR19A MVR-Angled 19G
FDA UDI
Class IActive
Mani Dia-Burs Preparation Set
FDA UDI
Class IActive
MANI Ophthalmic Knife MSL27-02 Slit-Angled 2.75mm
FDA UDI
Class IActive

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