FDA Registration
Active
🇺🇸 United States
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab
Reg #: 3003537036
·
FEI: 3003537036
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TECAN CDMO SOLUTIONS MH, CORP.
- Registration Number
- 3003537036
- FEI Number
- 3003537036
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18735 MADRONE PKWY.
- City
- MORGAN HILL
- State
- CA
- ZIP
- 95037
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221020
Owner / Operator
- Firm Name
- Tecan Group AG
- Operator Number
- 9050992
- Address
- 103 Seestrasse, --
- City
- Maennedorf
- State
- Zurich
- Postal Code
- 8708
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-03-01 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2023-03-01 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2023-03-01 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2023-03-01 |
Proprietary Names
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)