Zmachine

FDA UDI

Class II (US FDA UDI)

by General Sleep

Identity

Trade Name: Zmachine FDA UDI
Generic Name: Home-use sleep apnoea recording system FDA UDI
Model / Reference: Synergy FDA UDI

Identifiers

Primary DI / UDI-DI: B5663000010 FDA UDI
510(k) Number: K172986 FDA UDI
FDA Product Code: MNR FDA UDI
OMC FDA UDI
OLV FDA UDI
GMDN Term: Home-use sleep apnoea recording system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 FDA UDI
882.1400 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Home-use sleep apnoea recording system

Zmachine by General Sleep — 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: General Sleep

Sources (1)

FDA UDI 5fc78ddc-6f20-43eb-b29c-945d67994fb9 34 fields · synced May 31, 2026