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OptoMonitor
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref F2000510(k) K161263
by Opsens Inc.
Identity
- Device Name
- OptoMonitor EUDAMED
- Model / Reference
- F2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540184020003 EUDAMED
- Basic UDI-DI
- B-07540184020003 EUDAMED
- 510(k) Number
- K161263 FDA 510(k)
- FDA Product Code
- DXO FDA 510(k)
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2870 FDA 510(k)
- Regulation Number
- 870.2870 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: In-line arterial blood sampling set
OptoMonitor by Opsens Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161263 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K192340 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-07540184020003 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Opsens Inc.
- EUDAMED SRN
- CA-MF-000018361
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ed31fc81-fa5f-4bbd-b5e4-f20cfe5b562c 61 fields · synced Jul 17, 2026
- FDA 510(k) K161263 24 fields · synced May 18, 2026