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BiOM T2

FDA UDI

Class II (US FDA UDI)

by Bionx Medical Technologies, Inc.

Identity

Trade Name
BiOM T2 FDA UDI
Generic Name
Portable computer FDA UDI
Device Name
BiOM T2 Wireless Tuning Device FDA UDI
Model / Reference
2001219 FDA UDI
Description
BiOM T2 Wireless Tuning Device FDA UDI

Identifiers

Primary DI / UDI-DI
B15520012190 FDA UDI
FDA Product Code
ISW FDA UDI
GMDN Term
Portable computer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Portable computer

BiOM T2 by Bionx Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable computer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bionx Medical Technologies, Inc.

Sources (1)

  • FDA UDI 1963c406-bef2-4094-8d3f-c0a2753005e0 33 fields · synced May 31, 2026