Organization name

SWL Medizin GmbH

SRN

DE-MF-000008000

Manufacturer status

Active

• 1TD-MDR-0065/06/2026/02Issued
  Technical documentationNotified body: 2764Expiry: Jun 4, 2029

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Türkiye; available across 32 countries total.

Trade name

Helix

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.

04251790219592

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.

42517902MDS14EW

Reference / catalog number

MDS831959

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

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.

• Z12109001DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.