Falck Medical Multi-Function Applanation Tonometer

FDA UDI

Class II (US FDA UDI)

by Falck Medical, Inc.

Identity

Trade Name: Falck Medical Multi-Function Applanation Tonometer FDA UDI
Generic Name: Ophthalmic tonometer, line-powered FDA UDI
Device Name: Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement FDA UDI
Model / Reference: FMAT1 FDA UDI
Description: Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement FDA UDI

Identifiers

Primary DI / UDI-DI: 00867009000208 FDA UDI
FDA Product Code: HKY FDA UDI
GMDN Term: Ophthalmic tonometer, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1930 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 15 Centimeter FDA UDI
Length — 20 Centimeter FDA UDI
Depth — 5 Centimeter FDA UDI

Category: Ophthalmic tonometer, line-powered

Falck Medical Multi-Function Applanation Tonometer by Falck Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Falck Medical, Inc.

Sources (1)

FDA UDI ff71fa08-5a8a-45e7-b27f-eb4a46767852 35 fields · synced May 30, 2026