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MATRx Plus

FDA UDI

Class II (US FDA UDI)

by Zephyr Sleep Technologies, Inc.

Identity

Trade Name
MATRx Plus FDA UDI
Generic Name
Home-use sleep apnoea recording system FDA UDI
Model / Reference
MATRx plus CAT-024-03 FDA UDI

Identifiers

Primary DI / UDI-DI
B406CAT024030 FDA UDI
FDA Product Code
QCJ FDA UDI
MNR FDA UDI
GMDN Term
Home-use sleep apnoea recording system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5571 FDA UDI
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Home-use sleep apnoea recording system

MATRx Plus by Zephyr Sleep Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use sleep apnoea recording system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zephyr Sleep Technologies, Inc.

Sources (1)

  • FDA UDI a87351e6-9e0b-4fe4-bb2e-45e8b566e146 33 fields · synced May 29, 2026