Sonex-HL

FDA UDI

Class II (US FDA UDI)

by Nanosonics, Inc.

Identity

Trade Name: Sonex-HL FDA UDI
Generic Name: Medical device disinfection agent FDA UDI
Device Name: Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT) FDA UDI
Model / Reference: N00037 FDA UDI
Description: Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT) FDA UDI

Identifiers

Primary DI / UDI-DI: 09350855000023 FDA UDI
510(k) Number: K103059 FDA UDI
FDA Product Code: OUJ FDA UDI
GMDN Term: Medical device disinfection agent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

Category: Medical device disinfection agent

Sonex-HL by Nanosonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K103059 also covers:

Sonex-HL — NANOSONICS, INC.
Trophon EPR — NANOSONICS, INC.
Trophon EPR — NANOSONICS, INC.
Trophon EPR — NANOSONICS, INC.
trophon Curved Probe Positioner — NANOSONICS, INC.

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: Nanosonics, Inc.

Sources (1)

FDA UDI 990c6969-6ba0-4e5a-a4ce-37d53009f911 34 fields · synced Jun 1, 2026