Organization name

Institut Straumann AG

SRN

CH-MF-000009933

Manufacturer status

Active

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

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

• Consult instructions for use
• Do not re-use
• Do not use if package is damaged

Primary placement in Germany; available across 27 countries total.

Trade name

not provided

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.

07630031742179

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.

0763003170095R7

Reference / catalog number

035.2016S

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

TLX SP Implant, Ø 3.75mm NT, SLA® 16mm, Roxolid®

Additional information URL

https://ifu.straumann.com/

Clinical sizes

• 3.75 MU50
• 16 MU50

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

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

• P01020101DENTAL IMPLANTS

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.