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EUDAMED last updated this device on Apr 28, 2026
B-04260125713117Silverline® Subdural Drainage Catheter 8F is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by Spiegelberg GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04260125713117EVD30.015.02(01)04260125713117
European Medical Device Nomenclature — the EU product classification assigned to this device.
N010399INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHERA0601010402CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)1 warning recorded — scroll inside the panel to see all entries.
CW010DE-MF-000000008170772620Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 1, 2004 | Still on market |
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.
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.
B-04260125712684On the marketSilverline® Lumbar Drainage CatherterB-04260125713186On the marketSilverline® Subdural Drainage Catheter 10FB-04260125713100On the marketSilverline® Ventricular Drainage Catheter 10FB-04260125710307On the marketSilverline® Ventricular Drainage Catheter 8FB-04260125710185On the marketSilverline® Ventricular Drainage Catheter with Cranial Bolt 10FB-04260125713025On the marketCertificate health across this manufacturer's portfolio.
1000265951Issued1000265927Issued1000216002Issued1000210544IssuedNotified 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 →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 →