FDA.reportPublic FDA data

Onera STS 2

Primary DI
08720256698470
Brand
Onera STS 2
Company
Onera B.V.
Model
01.00
Catalog number
ONERA SLEEPMAP
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253668000Onera SleepMap (SLEEPMAP)Onera B.V.2026-03-08OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720256698470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720256698470087202566984708720256698470

GMDN Terms#

Term, Definition table
TermDefinition
Polysomnography analyserA mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.

Contacts#

Phone, Email table
PhoneEmail
+310403082177info@onerahealth.com

Regulatory Flags#

DUNS number
492293557
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720256698296Onera STS 201.00ONERA STS 2 – HEAD SENSOR A2026-05-15
08720256698302Onera STS 201.00ONERA STS 2 – HEAD SENSOR B2026-05-15
08720256698319Onera STS 201.00ONERA STS 2 – HEAD SENSOR C2026-05-15
08720256698326Onera STS 201.00ONERA STS 2 – CHEST SENSOR2026-05-15
08720256698333Onera STS 201.00ONERA STS 2 – FLOW SENSOR2026-05-15
08720256698340Onera STS 201.00ONERA STS 2 – LEG SENSOR2026-05-15
08720256698357Onera STS 201.00ONERA STS 2 – ONERA SLEEP APP ANDROID US2026-05-15
08720256698364Onera STS 201.00ONERA STS 2 – ONERA SLEEP APP iOS US2026-05-15
08720256698371Onera STS 201.00ONERA STS 2 – ONERA CLOUD DEVICE SERVICE2026-05-15
08720256698463Onera STS01.00ONERA STS1 CHEST US2026-05-15
08720256698487Onera STS01.00ONERA STS1 HEAD ADHESIVE A2026-05-15
08720256698494Onera STS01.00ONERA STS1 HEAD ADHESIVE B2026-05-15
08720256698500Onera STS01.00ONERA STS1 HEAD ADHESIVE C2026-05-15
08720256698517Onera STS01.00ONERA STS1 CHEST Adhesive2026-05-15
08720256698524Onera STS01.00ONERA STS1 LEG ADHESIVE2026-05-15
08720256698531Onera STS01.00ONERA STS1 LEG ADHESIVE2026-05-15
08720256698005Onera STS01.00ONERA STS1 HEAD2023-03-15
08720256698012Onera STS01.00ONERA STS1 CHEST2023-03-15
08720256698029Onera STS01.00ONERA STS1 HEAD CRADLE2023-03-15
08720256698036Onera STS01.00ONERA STS1 LEG2023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
00850049266055WavebandBeacon Biosignals, Inc.OLV2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLV2026-04-17
B566847020ZmachineGeneral SleepOLV2026-04-16
B566847001ZmachineGeneral SleepOLV2026-04-09