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Silicone Vessel ID Loops
EUDAMEDClass IIa (EU MDR)
Ref 9005-5013YModel 9005-5013W
Identity
- Trade Name
- Silicone Vessel ID Loops EUDAMED
- Device Name
- Silicone Vessel ID Loops EUDAMED
- Model / Reference
- 9005-5013W EUDAMED9005-5013Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182608818 EUDAMED
- Basic UDI-DI
- B-14711182608818 EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Silicone Vessel ID Loops by Fortune Medical Instrument Corp. — Class IIa — 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-14711182608818 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 348137af-16fa-4650-8314-ee49b8f35e56 61 fields · synced Jun 18, 2026