Is this your brand? Sign in to claim ownership.

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 8 of 46

Device	Model / Reference	Registries	Class	Status
MANI Ophthalmic Knife	MSL12SK Slit-Angled 1.2mm SK	FDA UDI	Class I	Active
MANI Ophthalmic Knife	MSS30 Slit 3.0mm	FDA UDI	Class I	Active
Mani Engine Reamers	25mm #55	FDA UDI	Class I	Active
MANI Ophthalmic Knife	MVR20ASK-02 MVR-Angled 20G SK	FDA UDI	Class I	Active
MANI Ophthalmic Knife	MSL25SH Slit-Angled 2.5mm SH	FDA UDI	Class I	Active
MANI Ophthalmic Knife	MST30-02 Straight 30°	FDA UDI	Class I	Active
Mani Pluggers	21mm #35	FDA UDI	Class I	Active
Mani Micro Files	TypeH #35	FDA UDI	Class I	Active
MANI NiTi FLARE FILES	21mm #40	FDA UDI	Class I	Active
Mani Micro Files	TypeH #25	FDA UDI	Class I	Active
Mani Micro Files	TypeH #20	FDA UDI	Class I	Active
Mani Gpr	1S	FDA UDI	Class I	Active
MANI NiTi FLARE FILES	25mm #15-40	FDA UDI	Class I	Active
Mani Micro Files	TypeH #15~40	FDA UDI	Class I	Active
NiTi H-FILES	25mm #40	FDA UDI	Class I	Active
Mani Micro Files	TypeF #30	FDA UDI	Class I	Active
Mani Gpr	2S	FDA UDI	Class I	Active
Mani Sutures Polyester - 5-0 Polyester	3372	EUDAMEDFDA UDI	Class IIb	Active
MANI SUPER FILES - 25mm #35	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Nylon - 7-0 Nylon	40	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Nylon - 10-0 Nylon	1052S	EUDAMEDFDA UDI	Class IIb	Active
MANI K-FILES - 31mm #90-140	-	EUDAMEDFDA UDI	Class I	Active
Mani Sutures Nylon - 11-0 Nylon	0550S	EUDAMEDFDA UDI	Class IIb	Active
MANI SEC O-FILES, K - 21mm #50	-	EUDAMEDFDA UDI	Class I	Active
Mani Sutures Nylon - 11-0 Nylon	1000S	EUDAMEDFDA UDI	Class IIb	Active
MANI SUPER FILES - 25mm #50	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Silk - 9-0 Silk	1480	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 8-0 Silk	2024	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Nylon - 7-0 Nylon	3364S	EUDAMEDFDA UDI	Class IIb	Active
JIZAI - 030 04 28mm	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 030 06 25mm	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Nylon - 6-0 Nylon	2808S	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 4-0 Silk	27	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 5-0 Silk	3355S	EUDAMEDFDA UDI	Class IIb	Active
JIZAI - 050 04 21mm	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 025 14 18mm/025 04, 025 06 25mm	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 030 06 31mm	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 013 04 25mm	-	EUDAMEDFDA UDI	Class IIa	Active
JIZAI - 025 06 31mm	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Nylon - 5-0 Nylon	2865	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 5-0 Silk	3856	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 8-0 Silk	2023	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 8-0 Silk	2019	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Polypropylene - 6-0 Polypropylene	3316	EUDAMED	Class IIb	Active
Mani Sutures Nylon - 5-0 Nylon	3383S	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Silk - 6-0 Silk	2801	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Polyester - 5-0 Polyester	3378	EUDAMEDFDA UDI	Class IIb	Active
Mani Sutures Nylon - 3-0 Nylon	13	EUDAMEDFDA UDI	Class IIb	Active
MANI SUPER FILES - 18mm MGP #20	-	EUDAMEDFDA UDI	Class IIa	Active
Mani Sutures Silk - 4-0 Silk	20	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Obelis s.a. BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.