Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014276972

FEI Number

3014276972

Entity Name

Mani Hanoi Co. Ltd Pho Yen 2 Factory

City/State/Country

Thai Nguyen Province, VN

Establishment Address

Plot CN5, Diem Thuy Industrial Zone - Area A, Pho Yen Ward,, Thai Nguyen Province -, VN

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 Sutures, Ophthalmic Sutures ( with Needle) Sutures (with needle) MANI Sutures Silk Manipler DSX 35W Manipler AZ 35W MANI Sutures, Ophthalmic Sutures (with Needle) MANI Sutures Polyester

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2007-04-19
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	Cardiovascular	Class 2	870.3470	2021-04-20
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2022-04-27
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-04-19
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2007-04-19

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
3004467019	MANI, INC. (HANAOKA FACTORY)	SHIOYA Tochigi, JP
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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014276972. Last updated year: 2026. Please use registration number 3014276972 when referencing this establishment in official correspondence.