Compumedics Grael

FDA UDI

by Compumedics Limited

Identity

Trade Name: Compumedics Grael FDA UDI
Generic Name: Polysomnograph FDA UDI
Device Name: Grael PSG starter kit FDA UDI
Model / Reference: Grael FDA UDI
Description: Grael PSG starter kit FDA UDI

Identifiers

Catalog Number: 7028-0008-01 FDA UDI
Primary DI / UDI-DI: 09342451001917 FDA UDI
510(k) Number: K093223 FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polysomnograph

Compumedics Grael by Compumedics Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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	N/A	Pending data

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Manufacturer

Manufacturer: Compumedics Limited

Sources (1)

FDA UDI c25a412c-4786-45f9-b074-4825a03b9dd0 37 fields · synced Jun 1, 2026