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Contract Medical International GmbH

US

Last updated May 30, 2026

Part of Contract Medical International GmbH

What Contract Medical International GmbH makes

Contract Medical International GmbH manufactures single-use vascular catheter introduction sets and cardiac/peripheral vascular guidewires, including the Catapult Guide Sheath and the Biotronik Fortress Introducer Sheath System. These products are designed for use in vascular procedures, providing support for catheter insertion and guidewire navigation in coronary and peripheral arteries.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) database. 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 Contract Medical International GmbH manufacture?

Contract Medical International GmbH specializes in single-use vascular medical devices. Their primary products include vascular catheter introduction sets (nonimplantable) and cardiac/peripheral vascular guidewires. These devices are specifically designed to assist in vascular procedures, such as guiding catheters and guidewires through coronary and peripheral arteries during interventions like angioplasty or stent placement.

Where is Contract Medical International GmbH based?

The company is headquartered in the United States. While the exact location isn’t specified, the regulatory data confirms its operational base is within the US, which is relevant for compliance with FDA requirements and UDI listing.

Which regulatory registries or databases list Contract Medical International GmbH’s devices?

Contract Medical International GmbH’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency of medical devices under FDA oversight, allowing healthcare providers and regulators to verify product details and compliance status.

How are Contract Medical International GmbH’s devices classified under FDA regulations?

All of Contract Medical International GmbH’s listed devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls (beyond general controls) to ensure safety and effectiveness, such as performance standards or post-market surveillance.

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

Information

Country
US
Address
—
Website
heraeus.com
LinkedIn
—
Facebook
—
Phone
+493512138888
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
330926895

Catalogue (44)

DeviceModel / ReferenceRegistriesClassStatus
Catapult Guide Sheath 6F, 90cm, RDC, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 15cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 45cm, Hockey stick, hydrophilic coated
FDA UDI
Class IIActive
Biotronik Fortress Introducer Sheath System 4F; 65 cm; straight
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 60cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 45cm, Multipurpose, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 90cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Biotronik Fortress Introducer Sheath System 4F; 100 cm; straight
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 45cm, RDC, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 45cm, Hockey stick, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 4F, 15cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 4F, 60cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 15cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 4F, 130cm, Straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 45cm, LIMA, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 4F, 45cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 45cm, RDC, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 130cm, Straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 8F, 45cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 60cm, straight, hydrophilic coated
FDA UDI
Class IIActive
MRWire Guidewire Angled MR Wire
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 45cm, Hockey stick, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 90cm, Hockey stick, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 45cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 45cm, Multipurpose, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 45cm, Multipurpose, hydrophilic coated
FDA UDI
Class IIActive
Biotronik Fortress Introducer Sheath System 6F; 65 cm; straight
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 90cm, Multipurpose, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 130cm, Straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 45cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 45cm, RDC, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 90cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 8F, 60cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 45cm, LIMA, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 8F, 90cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 4F, 90cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 8F, 15cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 60cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 45cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 7F, 90cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 5F, 15cm, straight, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 90cm, Hockey stick, hydrophilic coated
FDA UDI
Class IIActive
Catapult Guide Sheath 6F, 90cm, Multipurpose, hydrophilic coated
FDA UDI
Class IIActive
MRWire Guidewire Straight MR Wire
FDA UDI
Class IIActive

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