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EUDAMED last updated this device on Jul 24, 2026
B-03701459807338AB THERMO - T2/B is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by GROUPE SOBER SAS. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
03701459807338AB THERMO(01)03701459807338
European Medical Device Nomenclature — the EU product classification assigned to this device.
M030504IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES2 warnings recorded — scroll inside the panel to see all entries.
Veillez à utiliser la bonne taille et la bonne référence. Veillez à serrer les sangles modérément. La supervision d’un adulte est recommandée. Utiliser une protection contre la chaleur avant de tremper l’attelle dans le bain-marie. Assurez-vous que l’attelle ne touche pas le fond du bain-marie. Ne pas laisser l’attelle sans surveillance dans le bain-marie. Après passage au bain-marie, prenez soin de vérifier la température de l’attelle avant de l’appliquer au patient.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Nov 10, 2016 | Still on market |
FR-MF-000017818Sterile
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 →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.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.