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Organization name
UDI-DI code
Reference / catalog number

Silverline® Subdural Drainage… — Class III MDD

MD Atlas
Spiegelberg GmbH & Co. KG

EUDAMED last updated this device on Apr 28, 2026

Silverline® Subdural Drainage Catheter 10F

B-04260125713100

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Spiegelberg GmbH & Co. KG
UDI-DI code: 04260125713100
Reference / catalog number: EVD30.035.02

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Manufacturer information

Organization name: Spiegelberg GmbH & Co. KG
SRN: DE-MF-000000008
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 1, 2004	Still on market

Device identification

Trade name: Silverline® Subdural Drainage Catheter 10F
UDI-DI code: 04260125713100
Basic UDI-DI: B-04260125713100
Reference / catalog number: EVD30.035.02
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The subdural catheter drains cerebrospinal fluid (CSF) in adults for the treatment of chronic subdural haematomas. The proximal end is inserted into the subdural cavity for this purpose. The distal end is connected to a droplet chamber system (EVD set) or a drainage bag. The subdural catheter is impregnated with a silver additive to reduce the probability of microbial colonisation of its surface. CSF drainage is indicated for the following conditions, for example: traumatic brain injuries, acute hydrocephalus, subarachnoid haemorrhage (SAH), tumours and inflammatory conditions of the medulla oblongata.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10 MU170

EMDN nomenclature code(s)

A060301COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE
N010303CEREBRAL FLUID EXTERNAL DRAINS AND KITS
A0601010201DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

1000265951Issued
Technical documentationNotified body: 0297Expiry: Oct 22, 2030
1000265927Issued
Quality management systemNotified body: 0297Expiry: Mar 20, 2029
1000216002Issued
Technical documentationNotified body: 0297Expiry: Mar 12, 2030
1000210544Issued
Technical documentationNotified body: 0297Expiry: Mar 20, 2029