Magseed

FDA UDI

Class II (US FDA UDI)

by Endomagnetics Ltd

Identity

Trade Name: Magseed FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Magseed MagneticTissue Marker Length 12cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue. FDA UDI
Model / Reference: SM18-1-12US FDA UDI
Description: Magseed MagneticTissue Marker Length 12cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue. FDA UDI

Identifiers

Primary DI / UDI-DI: 15060391210107 FDA UDI
FDA Product Code: NEU FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Radiological image marker, implantable

Magseed by Endomagnetics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Endomagnetics Ltd

Sources (1)

FDA UDI 2fe7622c-e935-4324-9411-7946a069915e 33 fields · synced Jun 8, 2026