FDA Registration
Active
🇯🇵 Japan
MARCO AT-8 APPLANATION TONOMETER
Reg #: 9710516
·
FEI: 3001802794
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TAKAGI SEIKO CO., LTD.
- Registration Number
- 9710516
- FEI Number
- 3001802794
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 330-2 IWAFUNE
- City
- NAKANO-SHI Nagano
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K182491
Owner / Operator
- Firm Name
- TAKAGI SEIKO CO., LTD.
- Operator Number
- 9025906
- Address
- 330-2 IWAFUNE, --
- City
- NAKANO-SHI, NAGANO
- State
- JP-NOTA
- Postal Code
- 383-8585
- Country
- JP
- Correspondent
- TORU - HAGIWARA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2018-12-10 |
Proprietary Names
MARCO AT-8 APPLANATION TONOMETER
APPLANATION TONOMETER AT-2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device