Organization name

Opsens Inc.

SRN

CA-MF-000018361

Manufacturer status

Active

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

• Do not resterilize
• Do not re-use
• Do not use past indicated date
• Do not use if package is damaged
• Consult instructions for use

Primary placement in Germany; available across 26 countries total.

Trade name

not provided

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.

07540184010318

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-07540184010318

Reference / catalog number

F1031

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://opsensmedical.com/products/

Clinical sizes

• 0.014 MU28

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

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

• C04010101CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC

• Class III medical devices in EUDAMED

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