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EUDAMED last updated this device on Aug 13, 2026
B-08595565105113Interference screw flat thread 8/25 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.
08595565105113S0032700CZ-MF-000019992MED 200005(01)08595565105113
2 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 3 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Poland | — | Still on market |
| Slovakia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
P09120605INTERFERENCE SCREWSPrimary 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 →B-08595565105083On the marketInterference screw flat thread 7/30B-08595565105090On the marketInterference screw flat thread 8/20B-08595565105106On the marketInterference screw flat thread 8/30B-08595565105120On the marketInterference screw flat thread 9/20B-08595565105137On the marketInterference screw flat thread 9/25B-08595565105144On 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 →