FreezePoint® Freezing Point Osmometer

FDA UDI

Class I (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: FreezePoint® Freezing Point Osmometer FDA UDI
Generic Name: Osmometric analyser IVD FDA UDI
Device Name: FreezePoint Freezing Point Osmometer is intended for laboratory use by qualified personnel for the determination of total osmolality of aqueous solutions. FDA UDI
Model / Reference: Model 6000SP FDA UDI
Description: FreezePoint Freezing Point Osmometer is intended for laboratory use by qualified personnel for the determination of total osmolality of aqueous solutions. FDA UDI

Identifiers

Primary DI / UDI-DI: 03661540304705 FDA UDI
FDA Product Code: JJM FDA UDI
GMDN Term: Osmometric analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2730 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Osmometric analyser IVD

FreezePoint® Freezing Point Osmometer by Elitechgroup Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Elitechgroup Inc.

Sources (1)

FDA UDI ad2dfdb3-e55d-4624-b9f9-e998a3ead42f 35 fields · synced May 30, 2026