Pachymetry probe (45° fixed type)

FDA UDI

Class II (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name: Pachymetry probe (45° fixed type) FDA UDI
Generic Name: Ultrasound pachymeter FDA UDI
Device Name: It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000. FDA UDI
Model / Reference: 14610-0108 FDA UDI
Description: It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987669200100 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
GMDN Term: Ultrasound pachymeter 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ultrasound pachymeter

Pachymetry probe (45° fixed type) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound pachymeter.

Pachmate 2 Calbox — DGH Technology, Inc. · Class II
Pachette 3 Calbox — DGH Technology, Inc. · Class II
Gilras — U.S. OPHTHALMIC, L.L.C. · Class II
Pachmate Calbox — DGH Technology, Inc. · Class II
Gilras — U.S. OPHTHALMIC, L.L.C. · Class II
Single Measurement Calbox — DGH Technology, Inc. · Class II
Pachette 4 Calbox — DGH Technology, Inc. · Class II
Accupach VI — 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: Nidek, Inc.

Sources (1)

FDA UDI 53fbfb7a-8e8c-4c7a-806c-f081ec568829 34 fields · synced May 30, 2026