FDA Registration
Active
🇭🇺 Hungary
Tuttnauer Kft.
Reg #: 3027434168
·
FEI: 3027434168
·
Expires 2026
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tuttnauer Kft.
- Registration Number
- 3027434168
- FEI Number
- 3027434168
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43 Pallag Utca
- City
- Dunakeszi Pest
- Country
- HU
Regulatory Submissions
- 510(k) Number
- K181456
Owner / Operator
- Firm Name
- TUTTNAUER LTD.
- Operator Number
- 8030087
- Address
- HAR-TUV B INDUSTRIAL ZONE
- City
- BEIT SHEMESH
- State
- Jerusalem
- Postal Code
- 9910101
- Country
- IL
- Correspondent
- Keren Ziv
US Agent
- Business Name
- Tuttnauer USA
- Contact Name
- Guy Lerner
- Address
- 345 Oser Ave
- City
- Hauppauge
- State
- NY
- ZIP
- 11788
- Country
- US
- [email protected]
- Phone
- 516 3146011
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2019-10-22 |
Proprietary Names
Tuttnauer Horizontal models 4472, 5596, 6690, 66120, 69120, 69180
EZ9, EZ11, EZ15 - PLUS
1730, 2340, 2540, 3870 E/EK/EP, EZ9, EZ10, 3870 E/M, 2340, 2540, 3870 EA/EKA
Tuttnauer Steam Sterilizer
3870HSG and 3870HSG-WS
4472, 5596
Tuttnaier Table Top Autoclave
ELARA11
T-Edge10
T-Edge 11
T-Top 10, T-Top 11
1730, 2340, 2540, 3870 - E
6690, 66120, 69150, 6990, 69120, 69180
ELARAII
Elara 11
Tuttnauer Steam Sterilizer T-EDGE 10 & T-EDGE 11
Establishment Types
Manufacture Medical Device