Identity
- Trade Name
- Formula™ 535 EUDAMED
- Device Name
- Formula™ 535 Vascular Balloon-Expandable Stent EUDAMED
- Model / Reference
- FOV535-35-80-6-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002567405 EUDAMED
- Basic UDI-DI
- B-00827002567405 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™ 535 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-00827002567405 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Cook Incorporated
- EUDAMED SRN
- US-MF-000003180
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (1)
- EUDAMED 8981df9a-08d1-43d6-893e-f69d6da68f19 61 fields · synced Jun 19, 2026