Organization name

B. BRAUN MEDICAL SAS

SRN

FR-MF-000000674

Manufacturer status

Active

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

• Consult instructions for use
• Do not use past indicated date
• Do not re-use

Primary placement in Germany; available across 27 countries total.

Trade name

Flexima®-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.

04046955874927

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

62050X1

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

5

Additional product description

SAMPLE FLEX/SOFT KEY BASE PLATE 50/15-45

Additional information URL

https://eifu.bbraun.com/

Clinical sizes

• 50.00 MM
• cut-to-fit
• 15.00 - 45.00 MM

1 packaging level registered — each level carries its own UDI-DI.

• 04046955874927× 1 unitBase unit
  • 04046955876358× 40 units

• 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.