- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 14, 2024
42518308DiabeticusschuhZPSunderland schwarz/midnight/platin/schwarz Knautsch-Lack/Prägung/Metallica/Nubuk Weite WW is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Thanner GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
042518308140154.5174DE-MF-000032767(01)04251830814015
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y063303READY-MADE ORTHOTIC SHOESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.42518308DiabeticusschuhZPOn the marketSulfat schw/schw/dunkelblau Safety S142518308Vithana-SicherDAOn the marketSunderland schwarz/fumo/argento Nubuk/Mamba/Allure Weite S42518308DiabeticusschuhZPOn the marketSyrgenstein schw Nappa/Nappa gel Weite W42518308Vithana-StrasseZEOn the marketTajo es/wei/man/br Fettnu/Na/Sp/Sp W.M42518308DiabeticusschuhZPOn the marketTajo schwarz/grau/weiß Nap/Nub/Nap M42518308DiabeticusschuhZPOn the marketNo certificate specifically references this device's Basic UDI-DI.