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Onera STS
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ONERA STS I FLOW CRADLEModel Onera STS I
by Onera B.V.
Identity
- Trade Name
- Onera STS FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- Onera STS I EUDAMED
- Model / Reference
- Onera STS I EUDAMEDONERA STS I FLOW CRADLE EUDAMED01.00 FDA UDI
Identifiers
- Catalog Number
- ONERA STS1 FLOW CRADLE FDA UDI
- Primary DI / UDI-DI
- 08720256698067 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08720256698067 EUDAMED
- 510(k) Number
- K210593 FDA UDI
- FDA Product Code
- MNR FDA UDIOLV FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polysomnography analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI882.1400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Length — 160 Millimeter FDA UDIWidth — 80 Millimeter FDA UDIHeight — 86 Millimeter FDA UDIWeight — 290 Gram FDA UDI
Category: Polysomnography analyser
Onera STS by Onera B.V. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K210593 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Onera B.V.
Sources (2)
- FDA UDI ab5b356d-81cf-4b12-9afb-4be917d99645 37 fields · synced Jun 19, 2026
- EUDAMED 50dc1b47-fa6a-42e2-95de-7b8a2e89b15f 61 fields · synced Jun 19, 2026