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Morphic Medical, Inc.

United States US-MF-000019834 Last updated 21 Oct 2026

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Devices
1
Registries
EUDAMED
FDA recalls
0

Catalogue1

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

DNV Product Assurance AS 2460 1 certificate

  • 10000481475-PA-NoMA-USA Issued

    Quality management system EU MDR

    Issued
    12 Jun 2025
    Expires
    11 Jun 2030

Authorised representatives

Notified bodies

What Morphic Medical, Inc. makes

Morphic Medical, Inc. manufactures the RESET Retrieval System, a device designed for the removal of retained surgical items or foreign objects from the body. This system is intended for use in minimally invasive procedures to retrieve materials such as sponges, instruments, or other debris that may remain after surgery.

The RESET Retrieval System is classified as a Class IIa medical device and is listed in the EU’s eudamed registry. The company 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 Morphic Medical, Inc. manufacture?

Morphic Medical, Inc. specializes in the RESET Retrieval System, a device specifically designed for retrieving retained surgical items or foreign objects during minimally invasive procedures. This includes sponges, instruments, or other debris that may remain in the body post-surgery.

Where is Morphic Medical, Inc. based?

Morphic Medical, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly in markets like the U.S. and EU.

Which regulatory registries list Morphic Medical, Inc.’s devices?

The RESET Retrieval System is listed in the EU’s eudamed registry, which is the official database for medical devices authorized in the European Union. This registry helps healthcare professionals and regulators verify device details and compliance.

How are Morphic Medical, Inc.’s devices classified?

The RESET Retrieval System falls under Class IIa classification, which is the second-lowest risk category for medical devices in the EU. This classification is determined based on factors like the device’s intended use, potential risks, and clinical benefits, ensuring appropriate regulatory oversight.

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

Information

Country
United States
Address
320, Congress Street, Boston, United States
Phone
1-774-218-1375
PRRC contact
Stephen Linhares
EUDAMED SRN
US-MF-000019834