Organization name

Kettenbach GmbH & Co. KG

SRN

DE-MF-000005014

Manufacturer status

Active

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

E217148071

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

Profisil

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.

E217148071

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.

++E217PROFLUORID5XY

Reference / catalog number

14807

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.

HIBCC

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Profisil Fluoride Varnish Mint, Bulk pack, 300 x 0,5 ml, Mint

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.

• Q019008DENTINAL DESENSITISERS

• Class IIa medical devices in EUDAMED