B Probe 10MHz COMPACT TOUCH

FDA UDI

Class II (US FDA UDI)

by Quantel Medical

Identity

Trade Name: B Probe 10MHz COMPACT TOUCH FDA UDI
Generic Name: Ophthalmic ultrasound imaging transducer FDA UDI
Device Name: 10 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma. FDA UDI
Model / Reference: B1 COMPACT TOUCH FDA UDI
Description: 10 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma. FDA UDI

Identifiers

Primary DI / UDI-DI: 03700542625071 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Ophthalmic ultrasound imaging transducer 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ophthalmic ultrasound imaging transducer

B Probe 10MHz COMPACT TOUCH by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic ultrasound imaging transducer.

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Scanmate B — DGH Technology, Inc. · Class II
UBM 35 MHz Transducer — DGH Technology, Inc. · Class II
UBM Probe — DGH Technology, Inc. · Class II
UBM 50 MHz Transducer — DGH Technology, Inc. · 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

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Manufacturer

Manufacturer: Quantel Medical

Sources (1)

FDA UDI fab3fa86-f551-4cca-a109-5985ad50f76e 34 fields · synced Jun 8, 2026