Pocket

FDA UDI

Class II (US FDA UDI)

by Quantel Medical

Identity

Trade Name: POCKET FDA UDI
Generic Name: Ultrasound pachymeter FDA UDI
Device Name: Ultrasonic Pachymeter for Glaucoma Screening and Refractive Surgery. FDA UDI
Model / Reference: POCKET II FDA UDI
Description: Ultrasonic Pachymeter for Glaucoma Screening and Refractive Surgery. FDA UDI

Identifiers

Primary DI / UDI-DI: 03700542625040 FDA UDI
FDA Product Code: IYO FDA UDI
GMDN Term: Ultrasound pachymeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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: Ultrasound pachymeter

Pocket by Quantel Medical — 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
Pachymetry probe — Nidek, 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

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 023c39b4-35fb-45ad-a268-dffc1c273142 34 fields · synced Jun 8, 2026