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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 10 of 46

Device	Model / Reference	Registries	Class	Status
Mani Sutures Polyester - 4-0 Polyester	4355	EUDAMEDFDA UDI	Class IIb	Active
MANI MICRO FORCEPS - ILM 27G Slim Grip 33mm	MIL27	EUDAMED	Class IIa	Active
Mani Sutures Silk - 7-0 Silk	37	EUDAMEDFDA UDI	Class IIb	Active
MANI K-FILES - 21mm #40	-	EUDAMEDFDA UDI	Class I	Active
Mani Dia-Burs - Br-49c	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Dia-Burs - Br-34	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 035 04 28mm	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Silk - 6-0 Silk	3305	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 5-0 Silk	30	EUDAMEDFDA UDI	Class IIb	Active
MANI MICRO FORCEPS - Square Type 25G	MSQ25	EUDAMED	Class IIa	Active
Mani Sutures Nylon - 10-0 Nylon	1430	EUDAMED	Class IIb	Active
Mani Sutures Silk - 3-0 Silk	2	EUDAMEDFDA UDI	Class IIb	Active
MANI MICRO FORCEPS - Round 25G Wide Grip 33mm	MRD25A33	EUDAMED	Class IIa	Active
Mani Dia-Burs - Fo-25ef	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Polypropylene - 10-0 Polypropylene	2450	EUDAMED	Class IIb	Active
MANI H-FILES - 31mm #10	-	EUDAMEDFDA UDI	Class I	Active
Mani Dia-Burs - Fo-25c	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Silk - 4-0 Silk	17	EUDAMEDFDA UDI	Class IIb	Active
JIZAI - 040 04 28mm	-	EUDAMEDFDA UDI	Class IIa	Active
MANI SUPER FILES - 21mm MGP #10	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Nylon - 4-0 Nylon	23	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Nylon - 7-0 Nylon	1457	EUDAMEDFDA UDI	Class IIb	Active
Mani Needle & Suture Pack (pga Absorbable)	K053636	FDA 510(k)	Class II	Active
Mani Needle & Suture Pack	K050150	FDA 510(k)	Class II	Active
Mani Needle & Suture Pack (silk)	K053638	FDA 510(k)	Class II	Active
Mani Needle & Suture Pack (nylon)	K053637	FDA 510(k)	Class II	Active
Mani Dia-Burs - Pro-2	-	EUDAMEDFDA UDI	Class IIa	Active
MANI SEC O-FILES, H - 21mm #15	-	EUDAMEDFDA UDI	Class I	Active
Mani Sutures Silk - 7-0 Silk	2008	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Nylon - 9-0 Nylon	1407S	EUDAMEDFDA UDI	Class IIb	Active
MANI H-FILES - 25mm #80	-	EUDAMEDFDA UDI	Class I	Active
Mani Dia-Burs - Fo-22ef	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Dia-Burs - Wr-S31f	-	EUDAMEDFDA UDI	Class IIa	Active
MANI D FINDERS - 21mm #08-12	-	EUDAMEDFDA UDI	Class I	Active
MANI H-FILES - 25mm #90	-	EUDAMEDFDA UDI	Class I	Active
MANI OPHTHALMIC KNIFE - MVR-Angled 23G SK	MVR23ASK	EUDAMED	Class IIa	Active
MANI OPHTHALMIC KNIFE - Slit-Angled 1.2mm SK	MSL12SK	EUDAMED	Class IIa	Active
Mani Sutures Silk - 6-0 Silk	3366	EUDAMEDFDA UDI	Class IIb	Active
MANI OPHTHALMIC KNIFE - Crescent Double Bevel 1.0mm	MCB10	EUDAMED	Class IIa	Active
Mani Dia-Burs - Tr-257c	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Carbide Burs - 8(ca)	-	EUDAMED	Class IIa	Active
MANI OPHTHALMIC KNIFE - Slit-Angled 3.0mm SH	MSL30SH	EUDAMED	Class IIa	Active
Mani Sutures Nylon - 4-0 Nylon	12	EUDAMEDFDA UDI	Class IIb	Active
MANI REAMERS - 31mm #30	-	EUDAMEDFDA UDI	Class I	Active
Mani Dia-Burs - Si-61	-	EUDAMEDFDA UDI	Class IIa	Active
MANI ENGINE REAMERS - 18mm #25	-	EUDAMEDFDA UDI	Class IIa	Active
MANI H-FILES - 21mm #15-40	-	EUDAMEDFDA UDI	Class I	Active
Mani Sutures Nylon - 11-0 Nylon	1478S	EUDAMEDFDA UDI	Class IIb	Active
MANI SEC O-FILES, H - 21mm #25	-	EUDAMEDFDA UDI	Class I	Active
Mani Dia-Burs - Tc-12	-	EUDAMEDFDA UDI	Class IIa	Active

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