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EUDAMED last updated this device on Nov 15, 2022
++G073SEATING2BTherapiestuhl Nele Classic Gr.2 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Rehatec GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
G073101174801011748G07310117480
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y180980SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES1 warning recorded — scroll inside the panel to see all entries.
Vor der Versorgung mit dem Therapiestuhl sollte ärztlich abgeklärt werden, ob Kontraindikationen bestehen. Die Indikationen der Versorgung müssen in regelmäßigen Abständen von einem Arzt oder Therapeuten begleitet bzw. überwacht werden. Generell gilt: jede Art von Schmerzen stellt eine Kontraindikation dar! Unter folgenden Gegebenheiten und / oder Symptomen muss die aktive und / oder passive Verwendung des Geräts explizit mit dem behandelnden Arzt bzw. Therapeuten abgeklärt werden: Benutzer mit nicht intakter Haut; mit gravierender Tonus- Dysregulation. Das Gerät eignet sich nicht für Skoliose- Patienten. Dieser Therapiestuhl korrigiert keine Fehlhaltungen und eignet sich auch nicht zur Wachstumslenkung! Weitere Warnhinweise siehe Gebrauchsanweisung Kapitel 1.1 Sicherheitshinweise .
DE-MF-000006549Primary placement in Germany; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Oct 15, 2014 | Still on market |
| Austria | Oct 15, 2014 | Still on market |
| France | Oct 15, 2014 | Still on market |
| Luxembourg | Oct 15, 2014 | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 certificate specifically references this device's Basic UDI-DI.
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.++G073UNDERFRAMESQXOn the marketTherapiestuhl Nele Classic Gr.0++G073SEATING2BOn the marketTherapiestuhl Nele Classic Gr.1++G073SEATING2BOn the marketTherapiestuhl Nele Classic Gr.Mini++G073SEATING2BOn the marketTherapiestuhl Nele Gr.0++G073SEATING2BOn the marketTherapiestuhl Nele Gr.1++G073SEATING2BOn the market