Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004467019

FEI Number

3004467019

Entity Name

MANI, INC. (HANAOKA FACTORY)

City/State/Country

SHIOYA Tochigi, JP

Establishment Address

151 HANAOKA, OOAZA, TAKANEZAWA, SHIOYA Tochigi 329-1207, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MANI, INC. (HEAD OFFICE) (Owner Number: 8030343)

Owner / Operator Contact Address

8-3 KIYOHARA INDUSTRIAL PARK, --, UTSUNOMIYA, TOCHIGI, JP-NOTA 321-3231, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MANI Ophthalmic Knife Straight MANI TRABECULOTOMY HOOK MANI Ophthalmic Knife Guard Crescent Double Step - Angled 1 mm Slit MPK Golf/Scleral Rslit (Implant) MANI Ophthalmic Knife MVR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2002-05-01

Official Correspondent

Toshiharu Kamei

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

MANI, INC. (HEAD OFFICE)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007791573	Mani Hanoi Co. Ltd	Thai Nguyen Province, VN
8030343	MANI, INC. (TAKANEZAWA FACILITY)	SHIOYA Tochigi, JP
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
3014276972	Mani Hanoi Co. Ltd Pho Yen 2 Factory	Thai Nguyen Province, VN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

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8010851	BERNHARD FREY	TUTTLINGEN Baden-Wurttemberg, DE
2029275	Sterigenics U.S., LLC	Corona, CA, US
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004467019. Last updated year: 2026. Please use registration number 3004467019 when referencing this establishment in official correspondence.