FDA Registration
Active
🇯🇵 Japan
3-D MATRIX, LTD.
Reg #: 3007162658
·
FEI: 3007162658
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- 3-D MATRIX, LTD.
- Registration Number
- 3007162658
- FEI Number
- 3007162658
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Frontier Kojimachi Building 7F, Kojimachi 3-2-4
- City
- Chiyoda-ku Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K183015
Owner / Operator
- Firm Name
- 3-D Matrix, Ltd.
- Operator Number
- 10061211
- Address
- Frontier Kojimachi Building 7F, Kojimachi 3-2-4
- City
- Chiyoda-ku
- State
- Tokyo
- Postal Code
- 102-0083
- Country
- JP
- Correspondent
- Eri Kurita
US Agent
- Business Name
- 3D-Matrix
- Contact Name
- Alan Miskewicz
- Address
- 1234 Chestnut Street, Suite 205
- City
- Newton
- State
- MA
- ZIP
- 02464
- Country
- US
- [email protected]
- Phone
- 781 3739020
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2019-09-17 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2025-04-17 |
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | Class 2 | General, Plastic Surgery | No | 2022-02-02 |
Proprietary Names
PuraGel
Syringe Adapter
PuraStat
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device