Organization name

SOPHYSA

SRN

FR-MF-000002870

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 14 countries total.

Trade name

SOPHY® SM8 ADJUSTABLE VALVE / ANTECHAMBER

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.

03760124131215

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-03760124131215

Reference / catalog number

SM8A

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

Adjustable pressure valve for CSF shunting Sterility guaranteed unless package open or damaged. Radiopaque. Non-pyrogenic.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• N01038099INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER

• Class III medical devices in EUDAMED

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