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PT-MF-000012964DBSSO 2.0 tray (Delphos BSSO 2.0 System) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by DELPHOS IMPLANTS – Indústria, Comércio, Importação e Exportação de Implantes Médicos, S.A.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 11, 2026
56004617INST04G7Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05600461726263
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
CW010CW007Sterile
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 France; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jan 1, 2021 | Still on market |
| EL | Jan 1, 2022 | Still on market |
| Spain | Nov 1, 2023 | Still on market |
| Luxembourg | Aug 1, 2022 | Still on market |
| Latvia | Mar 1, 2023 | 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.
05600461726263Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
56004617INST04G7DA-0613-801UDI 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.
L091002INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE56004617INST04G7On the marketD3DS Tray 2.0mm (Delphos 3D System)56004617INST04G7On the marketDBSSO 2.0 tray (Delphos BSSO 2.0 System)56004617INST04G7On the marketDepth gauge - 0.8 and 1.0mm wires56004617INST09GHOn the marketDepth gauge - 1.2mm wires56004617INST09GHOn the marketDepth gauge - 1.8mm wires56004617INST09GHOn the marketNo 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.