BioXmark

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name: BioXmark FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Model / Reference: 11210590 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841439115114 FDA UDI
510(k) Number: DEN220017 FDA UDI
FDA Product Code: QUV FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5727 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological image marker, implantable

BioXmark by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

DEN220017 also covers:

BioXmark — Nanovi A/S

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: Medtec LLC

Sources (1)

FDA UDI eb80686b-7a81-4124-9bca-9f1ea04131ea 34 fields · synced May 30, 2026