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Zurich Medical

United States·US-MF-000012091

Last updated September 18, 2026

About

Zurich Medical is an innovator of cardiovascular devices that are based on proven science and supported by clinical and economic evidence. Our devices apply an appropriate level of technology designed for cost effectiveness and ease of use. We strive to help reduce health care costs around the world.

From the manufacturer's own website. Source

What Zurich Medical makes

The company manufactures reusable electrical-only medical device connection cables designed for interfacing with various medical equipment, including GE, Mindray, Draeger, Siemens, and Merge-McKesson systems. These cables feature standardized pin configurations such as 7-pin, 12-pin, 14-pin, 8-pin, and 3.5mm connectors, tailored for specific manufacturer compatibility and regional use. Examples include cables for GE 7-pin and 9-pin systems, Mindray 12-pin setups, and Draeger-Siemens 14-pin interfaces, often differentiated by type (A, C, or I) and country-specific variants. The portfolio covers both general-purpose and specialized connections for diagnostic and monitoring devices.

The devices fall under Class I, Class II, and Class III regulatory classifications, depending on their risk level and intended use. They are listed in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with global medical device regulations. The company is based in the United States, where its products are subject to FDA oversight and, where applicable, EU MDR requirements for market placement in the European Economic Area.

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 Zurich Medical manufacture?

Zurich Medical specializes in reusable electrical-only medical device connection cables. These cables are designed to interface with various medical equipment systems, such as those from GE, Mindray, Draeger, Siemens, and Merge-McKesson. The cables feature standardized pin configurations like 7-pin, 12-pin, 14-pin, 8-pin, and 3.5mm connectors, tailored to ensure compatibility with specific manufacturer systems and regional requirements.

Where is Zurich Medical based, and how does that affect its regulatory oversight?

Zurich Medical is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA oversight in the U.S. market. For devices marketed in the European Economic Area, compliance with EU MDR requirements applies, and these devices are listed in the EU’s eudamed registry. The company’s products are also included in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and regulatory compliance.

Which regulatory registries list Zurich Medical’s devices, and why is this important?

Zurich Medical’s devices are listed in the EU’s eudamed registry and the FDA’s UDI database. Listing in these registries is important because it ensures transparency, traceability, and compliance with global medical device regulations. eudamed supports EU MDR requirements, while the FDA’s UDI database helps track devices in the U.S. market, facilitating regulatory oversight and patient safety.

How are Zurich Medical’s devices classified under medical device regulations?

Zurich Medical’s devices fall under Class I, Class II, and Class III regulatory classifications. The classification depends on the risk level and intended use of each device. For example, cables with minimal risk to patients may qualify as Class I, while those with higher risk or more complex functions could be classified as Class II or Class III. This classification determines the regulatory scrutiny and requirements each device must meet.

Are Zurich Medical’s devices compatible with specific medical equipment brands, and how are they differentiated?

Yes, Zurich Medical’s cables are designed for compatibility with specific medical equipment brands like GE, Mindray, Draeger, Siemens, and Merge-McKesson. They are differentiated by pin configurations (e.g., 7-pin, 12-pin) and types (e.g., Type A, Type C, Type I), as well as country-specific variants. For example, a GE 7-Pin cable may have a different type designation depending on whether it is intended for use in China or another region, ensuring proper functionality and safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
2405, Xenium Lane N, Plymouth, United States
LinkedIn
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Facebook
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Phone
+1 612 889 9412
PRRC Contact
Kin-Joe Sham
EUDAMED SRN
US-MF-000012091
FDA FEI Number
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DUNS Number
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Catalogue (60)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Zurich Medical Accessory Cable Siemens 8-Pin, Type G
EUDAMEDFDA UDI
Class IIActive
Zurich Medical Accessory Cable Merge 3.5mm, Type C
EUDAMEDFDA UDI
Class IIActive
Zurich Medical Accessory Cable GE 9-Pin, Type I
EUDAMEDFDA UDI
Class IIActive
Zurich Medical Accessory Cable Draeger-Siemens 14-Pin, Type A
EUDAMEDFDA UDI
Class IIActive
Zurich Medical Accessory Cable Mindray 9-Pin, Type I
EUDAMEDFDA UDI
Class IIActive
Zurich Medical Accessory Cable Mindray 9-Pin, Type A
EUDAMEDFDA UDI
Class IIActive
Zurich Medical Accessory Cable GE 9-Pin, Type C
FDA UDI
Class IIActive
Zurich Pressure Guidewire System Model 100 K190852
FDA 510(k)
Class IIActive
Gpg 00308
EUDAMEDFDA UDI
Class IIIActive
Zmac 00512-001
EUDAMEDFDA UDI
Class IActive

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