FDA Registration
Active
🇺🇸 United States
TECAN CDMO SOLUTIONS MH, CORP.
Reg #: 3003537036
·
FEI: 3003537036
·
Expires 2026
Products
11
Proprietary Names
7
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- TECAN CDMO SOLUTIONS MH, CORP.
- Registration Number
- 3003537036
- FEI Number
- 3003537036
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18735 MADRONE PKWY.
- City
- MORGAN HILL
- State
- CA
- ZIP
- 95037
- Country
- US
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 |
|---|---|---|---|---|---|
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2021-11-04 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2021-11-04 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2026-02-05 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2023-06-08 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2021-10-08 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2021-11-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-10-08 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-10-08 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2022-08-23 |
| Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | PER | Class 1 | Clinical Chemistry | No | 2019-07-25 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2023-03-01 |
Proprietary Names
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System
Medical Device Data System_Avail Medsystem Inc.
Avive Connect
CATALYS Precision Laser System (Mobile Patient Bed)- JNJ
E-100 Electrosurgical Generator, SynchroSeal
CloudCath Peritoneal Dialysis Drain Set Monitoring System
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)