FDA Registration
Active
🇷🇴 Romania
CPJ84022 Dome Sterile, SP840 Physiological Pressure Transducer/ CPJ840J6
Reg #: 3009106351
·
FEI: 3009106351
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SC EUROMEDICA SRL
- Registration Number
- 3009106351
- FEI Number
- 3009106351
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12, Atelierului Street
- City
- Iasi
- Country
- RO
Regulatory Submissions
- 510(k) Number
- K792020
Owner / Operator
- Firm Name
- SC Euromedica SRL
- Operator Number
- 10035977
- Address
- 12, Atelierului Street
- City
- Iasi
- State
- RO-IS
- Postal Code
- 700154
- Country
- RO
- Correspondent
- Stefania Enache
US Agent
- Business Name
- Autobytec, LLC
- Contact Name
- Joe Huang
- Address
- 43422 West Oaks Drive, Suite 183
- City
- Novi
- State
- MI
- ZIP
- 48377
- Country
- US
- [email protected]
- Phone
- 248 6600380
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2017-09-25 |
Proprietary Names
CPJ84022 Dome Sterile, SP840 Physiological Pressure Transducer/ CPJ840J6
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)