FDA Registration
Active
🇯🇵 Japan
TOP CORPORATION
Reg #: 9610993
·
FEI: 3002808374
·
Expires 2026
Products
5
Proprietary Names
12
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- TOP CORPORATION
- Registration Number
- 9610993
- FEI Number
- 3002808374
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19-10 SENJU, NAKAI-CHO,
- City
- ADACHI-KU Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K843415
Owner / Operator
- Firm Name
- TOP CORPORATION
- Operator Number
- 8030272
- Address
- 19-10 SENJU, NAKAI-CHO
- City
- ADACHI-KU
- State
- Tokyo
- Postal Code
- 120-0035
- Country
- JP
- Correspondent
- Yuki HANAWA
US Agent
- Business Name
- Mazza Healthcare
- Contact Name
- Nicholas J. Mazza
- Address
- 2101 Waukegan Rd, Suite 208
- City
- Bannockburn
- State
- IL
- ZIP
- 60015
- Country
- US
- [email protected]
- Phone
- 847 2823446
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2008-03-02 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-03-02 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2014-11-26 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2008-03-02 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2018-08-27 |
Proprietary Names
TOP HYPODERMIC SYRINGE LUER LOCK
NRFit Syringe
TOP DISPOSABLE INFUSION SET
SYRINGE
TOP DISPOSABLE PLASTIC SYRINGES
TOP Infection Protection Kit
TOP DISPOSABLE SPINAL NEEDLE
Glass Syringe Slip 5 mL ISO neuraxial
Glass Syringe Slip 10 mL ISO neuraxial
Glass Syringe Lock 5 mL ISO neuraxial
Glass Syringe Lock 10 mL ISO neuraxial
WINGED INFUSION SET
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)