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OptoWire Deux Pressure Guidewire with Gauge Connector
EUDAMEDClass III (EU MDR)
Ref F1011
by Opsens Inc.
Identity
- Device Name
- OptoWire Deux Pressure Guidewire with Gauge Connector EUDAMED
- Model / Reference
- F1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540184010110 EUDAMED
- Basic UDI-DI
- B-07540184010110 EUDAMED
- EMDN Code
- C04010101 CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France 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 Deux Pressure Guidewire with Gauge Connector by Opsens Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07540184010110 | Class III | Active |
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Manufacturer
- Manufacturer
- Opsens Inc.
- EUDAMED SRN
- CA-MF-000018361
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED c6188ce4-8cca-4d3e-8b24-74cb09bfe9b1 61 fields · synced Oct 6, 2026