Tumark Vision MRI

FDA UDI

Class II (US FDA UDI)

by SOMATEX Medical Technologies GmbH

Identity

Trade Name: Tumark Vision MRI FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Model / Reference: 601590 FDA UDI

Identifiers

Primary DI / UDI-DI: 04250195611468 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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Radiological image marker, implantable

Tumark Vision MRI by SOMATEX Medical Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological image marker, implantable.

UltraClip® Dual Trigger Breast Tissue Marker — Bard Peripheral Vascular · Class II
SenoMark® UltraCor® Breast Tissue Marker — Bard Peripheral Vascular · Class II
Breast localisation needle — Möller Medical GmbH · Class I
Stellar Medical — Stellar Medical, LLC · Class II
SecurMark for ATEC — Hologic, Inc. · Class II
HydroMark — Devicor Medical Products, Inc. · Class II
AutoMark — M.D.L. S.R.L. · Class I
X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: SOMATEX Medical Technologies GmbH

Sources (1)

FDA UDI 00c55a99-8ff7-4f3b-8489-6fb2740705a5 32 fields · synced Jun 8, 2026