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EUDAMED last updated this device on Jul 10, 2026
B-08592395510056Silicone finger joint replacement 6 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by ProSpon, spol. s r.o.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CZ-MF-000019992MED 200002(01)08592395510056
3 warnings recorded — scroll inside the panel to see all entries.
Sterile
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 Czechia; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Slovakia | — | 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.
08592395510056Basic 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-08592395510056Z06110-0600-16062UDI 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.
P090403HAND PROSTHESES INTERPHALANGE COMPONENTSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →B-08592395510025On the marketSilicone finger joint replacement 4B-08592395510032On the marketSilicone finger joint replacement 5B-08592395510049On the marketSilicone finger joint replacement 7B-08592395510063On the marketSilicone finger joint replacement 8B-08592395510070On the marketSilicone Trapezium replacement 2B-08592395902233On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
2026-MDR/QS-032Issued2026-MDR/TD-003Issued2026-MDR/QS-003IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →