FDA Registration
Active
🇺🇸 United States
TUTTNAUER USA CO. LTD.
Reg #: 2435367
·
FEI: 2435367
·
Expires 2026
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TUTTNAUER USA CO. LTD.
- Registration Number
- 2435367
- FEI Number
- 2435367
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 345 Oser Avenue, --
- City
- HAUPPAUGE
- State
- NY
- ZIP
- 11788
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111736
Owner / Operator
- Firm Name
- TUTTNAUER USA CO. LTD.
- Operator Number
- 1450514
- Address
- 345 Oser Avenue, --
- City
- Hauppauge
- State
- NY
- Postal Code
- 11788
- Country
- US
- Correspondent
- Keren Ziv
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2024-12-19 |
Proprietary Names
EZ9 plus, EZ11 Plus
T-Edge 11 120V
T-Edge 11 230V
T-Edge 10 230V
T-Edge 10 120V
3870 HSG WS
3870 HSG
6690, 66120, 69150, 6990, 69120, 69180
2340M
2540M
Valueklave 1730MK
T-Top 11 230V
T-Top 10 120V
T-Top 10 230V
T-Top 11 120V
2540EEKEAEKA
3870EA, 3870EAP
2340EKA
EZ9
EZ10, EZ10P
Elara II, 5075 HSG MD
1730ME , 2340ME, 2540ME
4472, 5596, 6690, 6990, 66120, 69120, 69180
Establishment Types
Manufacture Medical Device