Axis Nano

FDA UDI

Class II (US FDA UDI)

by Quantel Medical

Identity

Trade Name: AXIS NANO FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Device Name: Ophthalmic Ultrasound Biometer: Biometry and IOL Calculation The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. FDA UDI
Model / Reference: AXIS NANO FDA UDI
Description: Ophthalmic Ultrasound Biometer: Biometry and IOL Calculation The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. FDA UDI

Identifiers

Primary DI / UDI-DI: 03700542625033 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 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 system

Axis Nano by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
Ellex — ELLEX MEDICAL PTY LTD · Class II
LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
B-scan Plus- VET — ACCUTOME, 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 b9597a34-ce6d-442f-813c-1ba690d76acc 34 fields · synced Jun 8, 2026