- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 30, 2025
B-03700401600577A41-GS35 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by Biotechni S.A.S. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
03700401600577A41-GS35(01)03700401600577
European Medical Device Nomenclature — the EU product classification assigned to this device.
P09010303GLENOSPHERES1 warning recorded — scroll inside the panel to see all entries.
Patients should be warned of these contraindications. Contraindications include: Conditions which can severely affect the success of the implantation: • Any local, acute, or chronic infection. Any infectious illness. Fever or leucocytosis. • Systemic and metabolic disorders. Any mental or neuromuscular disorder. • Deficient bone stock, osteopenia and/or severe osteoporosis. • Drug, tabacco and/or alcohol addiction and/or abuse. • Non terminated skeletal development. • Intense physical activity • Proved or suspect sensitivity to materials • Tumor unresectable or residual. • Pregnancy, obesity or overweight (BMI >25) These contraindications are of general order and not exhaustive, and the surgeon will have to evaluate each patient, in order to determine the risks specific to the surgery and the benefit for the patient
Primary placement in France; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jan 1, 2005 | Jun 16, 2026 |
| Romania | Jan 1, 2014 | Jun 16, 2026 |
FR-MF-000013608FR19/81843473Sterile
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.