Identity
- Trade Name
- Formula 418® t EUDAMED
- Device Name
- Formula 418® Vascular Balloon-Expandable Stent EUDAMED
- Model / Reference
- FOV418-18-135-6-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002566682 EUDAMED
- Basic UDI-DI
- B-00827002566682 EUDAMED
- EMDN Code
- P070402020101 STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Formula 418® t by Cook Incorporated — Class IIb — 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-00827002566682 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
- EUDAMED SRN
- US-MF-000003180
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (1)
- EUDAMED e3b58534-3ed8-405c-bdc9-532406528dc7 61 fields · synced Jul 23, 2026