- Role
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FR-MF-00000287035950SOPHY® SM8 KIT PREATTACHED/ BO19-10 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by SOPHYSA. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 2, 2026
B-03760124131123Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03760124131123
3 warnings recorded — scroll inside the panel to see all entries.
CW011CW009CW001Sterile
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 Belgium; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Oct 1, 1995 | Still on market |
| Bulgaria | Oct 1, 2008 | Still on market |
| Czechia | Oct 1, 1999 | Still on market |
| Germany | Dec 1, 1995 | Still on market |
| EL | Jun 1, 2000 | Still on market |
| Spain | Oct 1, 1996 | Still on market |
| France | Nov 1, 1995 | Still on market |
| Croatia | Jul 1, 2010 | Still on market |
| Italy | Nov 1, 1997 | Still on market |
| Lithuania | Apr 1, 2004 | Still on market |
| Poland | Oct 1, 2011 | Still on market |
| Romania | Oct 1, 2018 | Still on market |
| Sweden | Nov 1, 2023 | Still on market |
| Türkiye | Oct 1, 2003 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03760124131123Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-03760124131123SM8-2010UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
N01038099INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHERNo certificate specifically references this device's Basic UDI-DI.
B-03760124131918On the marketSOPHY® SM8 ADJUSTABLE VALVE / ANTECHAMBERB-03760124131215On the marketSOPHY® SM8 ADJUSTABLE VALVE / BURR HOLE RESERVOIRB-03760124131239On the marketSOPHY® SM8 KIT PREATTACHED/ PLO6B-03760124131154On the marketSOPHY® SM8 KIT PREATTACHED/ PLO7B-03760124131161On the marketSOPHY® SM8 KIT PREATTACHED/ PRO6B-03760124131130On the marketNo 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.