FDA Registration
Active
🇻🇳 Vietnam
Mani Hanoi Co. Ltd
Reg #: 3007791573
·
FEI: 3007791573
·
Expires 2026
Products
18
Proprietary Names
75
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- Mani Hanoi Co. Ltd
- Registration Number
- 3007791573
- FEI Number
- 3007791573
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Vang Residential group, Van Xuan Ward,
- City
- Thai Nguyen Province
- Country
- VN
Owner / Operator
- Firm Name
- MANI, INC. (HEAD OFFICE)
- Operator Number
- 8030343
- Address
- 8-3 KIYOHARA INDUSTRIAL PARK, --
- City
- UTSUNOMIYA, TOCHIGI
- State
- JP-NOTA
- Postal Code
- 321-3231
- Country
- JP
- Correspondent
- Toshiharu Kamei
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 1992-12-03 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2009-08-11 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2002-05-01 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1982-08-06 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2007-04-19 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2002-05-01 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2002-06-26 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2022-04-27 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 1981-10-01 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2002-06-26 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2007-04-19 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2007-04-19 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2007-04-19 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2007-04-19 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2018-09-12 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2002-05-01 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2010-05-14 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2002-10-29 |
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 Nylon
MANI ENT Knife
MANI PLUGGERS
FINGER PLUGGER
PLUGGER
MANI DISPOSABLE VESSEL KNIFE
MANI SHORT BARBED BROACHES
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)