Onera STS

FDA UDI

Class II (US FDA UDI)

by Onera B.V.

Identity

Trade Name: Onera STS FDA UDI
Generic Name: Polysomnography analyser FDA UDI
Model / Reference: 01.00 FDA UDI

Identifiers

Catalog Number: ONERA STS1 HEAD FDA UDI
Primary DI / UDI-DI: 08720256698005 FDA UDI
510(k) Number: K210593 FDA UDI
FDA Product Code: MNR FDA UDI
OLV FDA UDI
GMDN Term: Polysomnography analyser 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Weight — 34 Gram FDA UDI
Height — 26 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI
Width — 46 Millimeter FDA UDI

Category: Polysomnography analyser

Onera STS by Onera B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnography analyser.

Grass — S.L.P. INC.
Sleepsense — S.L.P. INC.
Sleepware — Respironics, Inc. · Class II
Sleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
Nox T3® System with WristOx2 — Nox Medical ehf. · Class II
Sleepware — Respironics, Inc. · Class II
Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
Sleepsense — S.L.P. INC.

Cleared under the same submission

K210593 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Onera B.V.

Sources (1)

FDA UDI 32a0509e-5079-4d1b-9aec-26362f1b5bfe 37 fields · synced May 30, 2026