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OptoWire III Pressure Guidewire
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref F1031510(k) K191907
by Opsens Inc.
Identity
- Device Name
- OptoWire III Pressure Guidewire EUDAMED
- Model / Reference
- F1031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540184010318 EUDAMED
- Basic UDI-DI
- B-07540184010318 EUDAMED
- EMDN Code
- C04010101 CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OptoWire III Pressure Guidewire by Opsens Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K191907 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07540184010318 | Class III | Active |
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Manufacturer
- Manufacturer
- Opsens Inc.
- EUDAMED SRN
- CA-MF-000018361
- FDA Applicant
- Opsens, Inc.
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED c3f56de4-4894-4377-9333-759d3a1e99da 85 fields · synced Jun 18, 2026
- FDA 510(k) K191907 1 fields · synced May 18, 2026