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Sign in to claim this brandTUTTNAUER ISRAEL LTD.
US
Last updated May 24, 2026
What TUTTNAUER ISRAEL LTD. makes
Tuttnauer Israel Ltd. manufactures steam sterilizers and surgical instrument washers/disinfectors, including chemical and thermal models. Their portfolio includes devices like the TIVA10 series, EZ11PLUS-P, and various washer/disinfectors (e.g., 4472, 5596-1R-L-USA). These products are designed for medical facility use to sterilize and clean surgical instruments.
The company’s devices fall under FDA Class II classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the US, adhering to regulatory requirements for medical device compliance in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Tuttnauer Israel Ltd. manufacture?
Tuttnauer Israel Ltd. specializes in two primary categories of medical devices: steam sterilizers and surgical instrument washers/disinfectors. These include both chemical and thermal disinfection models, such as the TIVA10 series (e.g., TIVA10-2V-HS-MD) and washers like the EZ11PLUS-P. Their products are engineered for use in healthcare settings to ensure the sterilization and cleaning of surgical instruments, addressing critical infection control needs.
Where is Tuttnauer Israel Ltd. based, and how does this affect its devices?
Tuttnauer Israel Ltd. is based in the US, which means its devices must comply with the regulatory framework governing medical devices in that jurisdiction. The company’s location ensures its products align with FDA requirements, including classification and listing in the FDA’s Unique Device Identifier (UDI) database, which is essential for traceability and regulatory transparency.
Which regulatory registries list Tuttnauer Israel Ltd.’s devices?
Tuttnauer Israel Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and identifying medical devices in the US, ensuring compliance with regulatory standards and facilitating transparency in the supply chain. The UDI system helps healthcare providers and regulators verify device details, including manufacturer information and classification.
How are Tuttnauer Israel Ltd.’s devices classified under FDA regulations?
Tuttnauer Israel Ltd.’s devices fall under FDA Class II classification. This classification is assigned based on the risk posed by the device—Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. Steam sterilizers and surgical instrument washers/disinfectors are typically classified as Class II due to their role in infection control and patient safety, requiring validation of performance and compliance with specific regulatory guidelines.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 600030209
Catalogue (78)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tiva10-2v-Hs-Md | TIVA10-2V-HS-MD | FDA UDI | Class II | Active |
| Ez11plus-P | EZ11PLUS-P | FDA UDI | Class II | Active |
| 4472 | 4472-1V | FDA UDI | Class II | Active |
| 5596-1r-L-Usa | 5596-1R Model | FDA UDI | Class II | Active |
| Model 5596-1V | Model 5596-1V | FDA UDI | Class II | Active |
| 2540mk | 2540MK | FDA UDI | Class II | Active |
| 69180 | 69180-1A | FDA UDI | Class II | Active |
| 3870m | 3870M | FDA UDI | Class II | Active |
| Model 6690-1V | Model 6690-1V | FDA UDI | Class II | Active |
| T-Edge 11 | AMS11-120-T | FDA UDI | Class II | Active |
| Model 6990-1A | Model 6990-1A | FDA UDI | Class II | Active |
| Tiva10-1v-Hs-Md | TIVA10-1V-HS-MD | FDA UDI | Class II | Active |
| 69120 | 69120-1A | FDA UDI | Class II | Active |
| Model 66120-1V | Model 66120-1V | FDA UDI | Class II | Active |
| 3870ea | 3870EA | FDA UDI | Class II | Active |
| Model 69180-1A | Model 69180-1A | FDA UDI | Class II | Active |
| Model 4472-1V | Model 4472-1V | FDA UDI | Class II | Active |
| Ez9 | EZ9 | FDA UDI | Class II | Active |
| 69180 | 6695180-1A | FDA UDI | Class II | Active |
| Model 69120-1A | Model 69120-1A | FDA UDI | Class II | Active |
| Model 69180-2A | Model 69180-2A | FDA UDI | Class II | Active |
| 69120 | 6695120-2A | FDA UDI | Class II | Active |
| Model 6990-2A | Model 6990-2A | FDA UDI | Class II | Active |
| 3870ea | 3870EA | FDA UDI | Class II | Active |
| 6990 | 6990-1A | FDA UDI | Class II | Active |
| Model 5596-1V | Model 5596-1V | FDA UDI | Class II | Active |
| 2340m | 2340M | FDA UDI | Class II | Active |
| Ez11plus | EZ11PLUS | FDA UDI | Class II | Active |
| Model 4472 | Model 4472 | FDA UDI | Class II | Active |
| Model 4472-1V | Model 4472-1V | FDA UDI | Class II | Active |
| Ez9 | EZ9 | FDA UDI | Class II | Active |
| Model 6690-2V | Model 6690-2V | FDA UDI | Class II | Active |
| 69120 | 69120-2A | FDA UDI | Class II | Active |
| 69150 | 6695150-1A | FDA UDI | Class II | Active |
| 69150 | 6695150-2H | FDA UDI | Class II | Active |
| Ez10 | EZ10 | FDA UDI | Class II | Active |
| T-Edge 10 | T-Edge 10 | FDA UDI | Class II | Active |
| T-Edge 10 | T-Edge 10 | FDA UDI | Class II | Active |
| T-Edge 11 | AMS11-230-T | FDA UDI | Class II | Active |
| Ez10 | EZ10 | FDA UDI | Class II | Active |
| 69120 | 69120-1R | FDA UDI | Class II | Active |
| Model 66120-2V | Model 66120-2V | FDA UDI | Class II | Active |
| Model 5596-2V | Model 5596-2V | FDA UDI | Class II | Active |
| 3870hsg | 3870HSG-WS-230-D | FDA UDI | Class II | Active |
| 4472 | 4472-1R | FDA UDI | Class II | Active |
| T-Edge 11 | AMS11-120-W-T | FDA UDI | Class II | Active |
| 5075hsg | 5075HSG - M | FDA UDI | Class II | Active |
| Tiva2-H Td | TIVA2-H TD | FDA UDI | Class II | Active |
| T-Edge 11 | AMS11-230-W-T | FDA UDI | Class II | Active |
| 2540mka | 2540MKA | FDA UDI | Class II | Active |
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