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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: —
Email: [email protected]
Phone: —
PRRC Contact: Toshiharu Kamei
EUDAMED SRN: JP-MF-000017860
FDA FEI Number: —
DUNS Number: 690622428

Catalogue (2255)

Page 38 of 46

Device	Model / Reference	Registries	Class	Status
MANI OPHTHALMIC KNIFE - Slit-Angled 1.6mm	MSL16	EUDAMED	Class IIa	Active
MANI Stainless Burs HARD - 28mm #6	-	EUDAMEDFDA UDI	Class IIa	Active
MANI OPHTHALMIC KNIFE - Straight 30°SK	MST30SK	EUDAMED	Class IIa	Active
Mani Sutures Silk - 8-0 Silk	2051	EUDAMEDFDA UDI	Class IIb	Active
MANI FLEXILE FILES - 21mm #15	-	EUDAMEDFDA UDI	Class I	Active
MANI SPREADERS - 21mm #30	-	EUDAMEDFDA UDI	Class IIa	Active
MANI H-FILES - 18mm #15-40	-	EUDAMEDFDA UDI	Class I	Active
Mani Dia-Burs - Br-32ef	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Dia-Burs - Mp-1	-	EUDAMEDFDA UDI	Class IIa	Active
MANI SUPER FILES - 25mm MGP #20	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 025 04 25mm	-	EUDAMEDFDA UDI	Class IIa	Active
MANI OPHTHALMIC KNIFE - Crescent Bevel Up 2.0mm	MCU20	EUDAMED	Class IIa	Active
Mani Sutures Nylon - 10-0 Nylon	1452	EUDAMEDFDA UDI	Class IIb	Active
MANI REAMERS - 25mm #40	-	EUDAMEDFDA UDI	Class I	Active
Mani Carbide Burs - 21dc	-	EUDAMEDFDA UDI	Class IIa	Active
MANI OPHTHALMIC KNIFE - Slit-Angled 2.2mm	MSL22	EUDAMED	Class IIa	Active
MANI K-FILES - 28mm #55	-	EUDAMEDFDA UDI	Class I	Active
Jizai - 020 04/025 04/025 06(31㎜)	-	EUDAMEDFDA UDI	Class IIa	Active
MANI H-FILES - 31mm #80	-	EUDAMEDFDA UDI	Class I	Active
MANI RT FILES - 31mm #50	-	EUDAMEDFDA UDI	Class I	Active
MANI K-FILES - 25mm #110	-	EUDAMEDFDA UDI	Class I	Active
MANI OPHTHALMIC KNIFE - Golf/Scleral 2.4mm	MGL24	EUDAMED	Class IIa	Active
Mani Dia-Burs - Mp-10f	-	EUDAMEDFDA UDI	Class IIa	Active
MANI REAMERS - 18mm #35	-	EUDAMEDFDA UDI	Class I	Active
MANI REAMERS - 18mm #15-40	-	EUDAMEDFDA UDI	Class I	Active
Mani Carbide Burs - 37	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Carbide Burs - 330	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Silk - 4-0 Silk	4302S	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Polypropylene - 10-0 Polypropylene	1415	EUDAMED	Class IIb	Active
JIZAI - 040 04 31mm	-	EUDAMEDFDA UDI	Class IIa	Active
MANI REAMERS - 31mm #110	-	EUDAMEDFDA UDI	Class I	Active
MANI MI STAINLESS BURS - 28mm #4	-	EUDAMEDFDA UDI	Class IIa	Active
MANI SPREADERS - 21mm #40	-	EUDAMEDFDA UDI	Class I	Active
MANI OPHTHALMIC KNIFE - R Slit-Angled 5.2mm	MRS52	EUDAMED	Class IIa	Active
JIZAI - 025 14 21mm	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Carbide Burs - 1957	-	EUDAMEDFDA UDI	Class IIa	Active
MANI OPHTHALMIC KNIFE - Guard Knife LRI 550μm	MLR55	EUDAMED	Class IIa	Active
MANI REAMERS - 28mm #08	-	EUDAMEDFDA UDI	Class I	Active
MANI OPHTHALMIC KNIFE - MVR-Angled 24G SK	MVR24ASK	EUDAMED	Class IIa	Active
MANI H-FILES - 31mm #35	-	EUDAMEDFDA UDI	Class I	Active
MANI MI STAINLESS BURS - 22mm #4	-	EUDAMEDFDA UDI	Class IIa	Active
MANI Stainless Burs HARD - 28mm #2	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Dia-Burs - Tr-258sc	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Silk - 8-0 Silk	1466	EUDAMEDFDA UDI	Class IIb	Active
MANI H-FILES - 18mm #08	-	EUDAMEDFDA UDI	Class I	Active
MANI OPHTHALMIC KNIFE - Straight-Angled 15°	MST15A	EUDAMED	Class IIa	Active
MANI SEC O-FILES, H - 21mm #60	-	EUDAMEDFDA UDI	Class I	Active
Mani Sutures Nylon - 6-0 Nylon	3382	EUDAMEDFDA UDI	Class IIb	Active
MANI SEC O-FILES, K - 25mm #15	-	EUDAMEDFDA UDI	Class I	Active
MANI SUPER FILES - 25mm #25	-	EUDAMEDFDA UDI	Class IIa	Active

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