- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jul 24, 2026
B-03760035440123STABILITY PERFUSION - H11 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.
03760035440123STABILITY PERFUSION(01)03760035440123
European Medical Device Nomenclature — the EU product classification assigned to this device.
M030599IMMOBILISATION SYSTEMS AND DEVICES - OTHER2 warnings recorded — scroll inside the panel to see all entries.
La mise en place de ce produit est réalisée sous la responsabilité d’un professionnel de santé qualifié. Le praticien doit donner toutes les informations sur le produit au patient. Ce produit ne doit pas être en contact direct avec une plaie.
Veillez à utiliser la bonne taille et la bonne référence. Ne pas laisser le patient sans surveillance. Veiller à serrer les sangles modérément. Ne convient pas à des patients agités ou perturbés. Ne pas laisser les perfusions ou autres à la portée du patient. La supervision d’un adulte est recommandée.
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 →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.B-03760035442318On the marketSTABILITY PELVIEN - TMB-03760035442301On the marketSTABILITY PELVIEN - TSB-03760035442295On the marketSTABILITY PERFUSION - H13B-03760035440130On the marketSTABILITY PERFUSION - H17B-03760035440147On the marketSTABILITY PERFUSION - H21/AB-03760035440161On the market