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Embrace Medical , Ltd.

US

Last updated May 30, 2026

What Embrace Medical , Ltd. makes

Embrace Medical, Ltd. manufactures manual peripheral vascular guidewires designed for use in interventional procedures, including coronary and peripheral angiography.

The company’s products are regulated as Class II devices in the U.S. and are listed under FDA 510(k) and UDI registries. The manufacturer is based in the United States.

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 Embrace Medical, Ltd. manufacture?

Embrace Medical, Ltd. specializes in manual peripheral vascular guidewires. These devices are specifically designed for interventional procedures such as coronary and peripheral angiography, where precise guidance within blood vessels is required.

Where is Embrace Medical, Ltd. based?

The company is headquartered in the United States. This location aligns with its regulatory focus on U.S. compliance standards for its medical devices.

How are Embrace Medical, Ltd.’s devices classified under U.S. regulations?

Embrace Medical, Ltd.’s devices are classified as Class II under U.S. regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as peripheral vascular guidewires.

Which regulatory registries list Embrace Medical, Ltd.’s devices?

Embrace Medical, Ltd.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process ensures compliance with premarket notification requirements, while UDI helps track and trace devices throughout their lifecycle.

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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LinkedIn
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Facebook
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Email
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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
532377560

Catalogue (5)

DeviceModel / ReferenceRegistriesClassStatus
TalWire SP-4003-002
FDA UDI
Class IIActive
TalWire SP-4003-008
FDA UDI
Class IIActive
TalWire SP-4003-004
FDA UDI
Class IIActive
TalWire SP-4003-006
FDA UDI
Class IIActive
TalWire K223791
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Embrace Medical Ltd. Tel Aviv · IL FEI 3024743081