FDA Registration
Active
🇯🇵 Japan
OEM SYSTEMS CO. LTD.
Reg #: 1000487132
·
FEI: 1000487132
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- OEM SYSTEMS CO. LTD.
- Registration Number
- 1000487132
- FEI Number
- 1000487132
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 84 MEKAWA MAKISHIMA-CHO
- City
- UJI-SHI Kyoto
- Country
- JP
Owner / Operator
- Firm Name
- OEM SYSTEMS CO. LTD.
- Operator Number
- 9050895
- Address
- 84 MEKAWA MAKISHIMA-CHO
- City
- UJI-SHI KYOTO
- State
- JP-NOTA
- Postal Code
- 6110041
- Country
- JP
- Correspondent
- Kenneth Block
US Agent
- Business Name
- Ken Block Consulting
- Contact Name
- Kenneth Block
- Address
- 3400 N Central Expy Ste 100265
- City
- Richardson
- State
- TX
- ZIP
- 75080
- Country
- US
- [email protected]
- Phone
- 972 4809554
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abnormal Hemoglobin Quantitation | GKA | Class 2 | Hematology | No | 2023-01-26 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2023-01-26 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-01-26 |
| Hemoglobin A2 Quantitation | JPD | Class 2 | Hematology | No | 2023-01-26 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2023-01-26 |
| System, Automated Platelet Aggregation | JOZ | Class 2 | Hematology | No | 2020-03-16 |
Proprietary Names
Variant Newborn Hemoglobin Screening System
Variant II Turbo Link
Variant nbs Newborn Screening System
Variant II Hemoglobin System
T-TAS 01 Total Thrombus Formation Analysis System Instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)