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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

External Ventricular Drainage Set… — Class I MDD

MD Atlas
Spiegelberg GmbH & Co. KG

EUDAMED last updated this device on Apr 28, 2026

External Ventricular Drainage Set with Plate and Clamp

B-04260125710161

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Spiegelberg GmbH & Co. KG
UDI-DI code: 04260125710161
Reference / catalog number: EVD30.004.01

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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	Feb 1, 2000	Still on market

Device identification

Trade name: External Ventricular Drainage Set with Plate and Clamp
UDI-DI code: 04260125710161
Basic UDI-DI: B-04260125710161
Reference / catalog number: EVD30.004.01
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The EVD kit serves for the drainage and collection of cerebrospinal fluid (CSF) as well as other fluids with similar physical properties for the temporary reduction and control of cerebral pressure. Among other things, CSF drainage is indicated in traumatic brain injury, acute hydrocephalus, subarachnoid hemorrhage, a tumor or inflammation of the cerebrospinal space. It is intended for connection to a ventricle catheter with Luer-Lock connector.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

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

Related devices

External Ventricular Drainage SetB-04260125710116On the market IAP CatheterB-04260125712707On the market ICP MonitorB-04260125713445On the market Parenchymal Probe 4F426012571ICP3STXMOn the market Parenchymal Probe 4F with Cranial Bolt426012571ICP3STXMOn the market

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