Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007791573

FEI Number

3007791573

Entity Name

Mani Hanoi Co. Ltd

City/State/Country

Thai Nguyen Province, VN

Establishment Address

Vang Residential group, Van Xuan 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

MI Stainless Burs MANI STAINLESS BURS MANI STAINLESS BURS HARD MANI CARBIDE BURS MANI Plug MANI Trocar Kit MANI Trocar MANI Infusion Cannula MANI SPREADERS FINGER SPREADER MANI FLARE SPREADERS SPREADER Paste Fillers MANI GLIDE FINDERS MANI JIZAI MANI H-FILES MANI FLEXILE FILES MANI PASTE CARRIERS JIZAI GLIDER MANI MEDIUM FLEXILE FILES MANI MICRO FILES TYPE H MANI FLARE FILES MANI K-FILES MANI MEDIUM FLARE FILES MANI SEC O-FILES, H MANI RT FILES MANI FLARE FILES NiTi MANI SEC O-FILES, K MANI MICRO FILES TYPE K MANI H-FILES NiTi MANI NiTi FILES MANI MICRO FILES TYPE F MANI SUPER FILES MANI MEDIUM H-FILES MANI MEDIUM K-FILES MANI D FINDERS MANI MICRO FILES TYPE U MANI SEC O-FILES MANI NiTi FILES R MANI U-FILES MANI Sutures, Ophthalmic Sutures ( with needle) MANI Sutures PGA 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 Peeso Reamers Gates Drills MANI GATES DRILLS MANI PEESO REAMERS Manipler DSX 35W Manipler AZ 35W MANI MEDIUM REAMERS MANI REAMERS MANI ENGINE REAMERS MANI DIA-BURS MANI Sutures, Ophthalmic Sutures (with Needle) MANI Sutures Polyester MANI Sutures, Ophthalmic Sutures ( with Needle) Sutures (with needle) MANI Sutures Silk MANI Sutures, Ophthalmic Sutures ( with Needle) MANI Sutures Nylon MANI ENT Knife MANI PLUGGERS FINGER PLUGGER PLUGGER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJL	Bur, Dental	Dental	Class 1	872.3240	1992-12-03
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-08-11
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2002-05-01
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1982-08-06
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-04-19
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2002-05-01
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2002-06-26
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2022-04-27
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	1981-10-01
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2002-06-26
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
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2007-04-19
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-04-19
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-09-12
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	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
3004467019	MANI, INC. (HANAOKA FACTORY)	SHIOYA Tochigi, JP
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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3004362293	CROSSTECH DIAMOND TOOLS CO., LTD.	Samutprakran Samut Prakan, TH
3010021780	NINGBO SINYUAN BUR & TOOL CO.,LTD.	Ningbo Zhejiang, CN
3023339159	MULLER INDIA PRIVATE LIMITED	GURGAON Haryana, IN
3008346537	CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING CO., LTD.	Cangzhou Hebei, CN
3007283751	CAMLOG Biotechnologies GmbH	Basel Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007791573. Last updated year: 2026. Please use registration number 3007791573 when referencing this establishment in official correspondence.