Organization name

B. BRAUN MEDICAL SAS

SRN

FR-MF-000000674

Manufacturer status

Active

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

• CW032

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

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 27 countries total.

Trade name

Softima®

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.

04046955755875

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.

4039239000000132ZE

Reference / catalog number

62040E

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 I

Applicable legislation

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

Status

On the market

Quantity

10

Additional product description

SOFTIMA KEY BASE PLATE 40/15-35

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 15.00 - 35.00 MM
• 40.00 MM
• cut-to-fit

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

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

• A1002010401UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH NON-INTROFLEX STOMA

• Class I medical devices in EUDAMED

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