Organization name

Cook Incorporated

SRN

US-MF-000003180

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 31 countries total.

Trade name

Formula™ 535

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00827002567405

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-00827002567405

Reference / catalog number

FOV535-35-80-6-20

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Vascular Balloon-Expandable Stent

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 20 MU50
• Catheter length — 80 MU10
• wire guide lumen — 0.035 MU28
• 6 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P070402020101STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.