Organization name

Contract Medical International GmbH

SRN

DE-MF-000007409

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date
• It is the responsibility of the physician to determine whether any physical impairment of the patient would contraindicate the use of this device.

  OTHER

Primary placement in Austria; available across 24 countries total.

Trade name

Fortress®

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.

04251244500948

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-04251244500948

Reference / catalog number

452387

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.biotronik.com/en-de/products/peripheral/fortress

Clinical sizes

No clinical sizes registered for this device.

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

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

• C0599CARDIOVASCULAR INTRODUCER SHEATHS - OTHER

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.