Morphic Medical, Inc.
United States US-MF-000019834 Last updated 21 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
RESET Retrieval System Ref 3000627
EUDAMED certificates
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
Related companies
Authorised representatives
- MDSS GmbH DE
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.
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.
Information
- Country
- United States
- Address
- 320, Congress Street, Boston, United States
- Website
- Morphicmed.com
- [email protected]
- Phone
- 1-774-218-1375
- PRRC contact
- Stephen Linhares
- EUDAMED SRN
- US-MF-000019834