Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Parenchymal Probe 4F with tunneling — Class III MDR

MD Atlas
Spiegelberg GmbH & Co. KG

EUDAMED last updated this device on Apr 23, 2026

Parenchymal Probe 4F with tunneling

426012571ICP3STXM

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Spiegelberg GmbH & Co. KG
UDI-DI code: 04260125713827
Reference / catalog number: ICP.3.04.02

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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	Oct 1, 2026	Still on market

Device identification

Trade name: Parenchymal Probe 4F with tunneling
UDI-DI code: 04260125713827
Basic UDI-DI: 426012571ICP3STXM
Reference / catalog number: ICP.3.04.02
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The variants of the parenchymal probe are used to monitor parenchymal, intracranial pressure (ICP). They are intended for short term use (continuous use for between 60 minutes and 30 days).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 4 MU170

EMDN nomenclature code(s)

Z12039001INTRACRANIAL PRESSURE MEASURING SYSTEMS

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 External Ventricular Drainage Set with Plate and ClampB-04260125710161On the market IAP CatheterB-04260125712707On the market ICP MonitorB-04260125713445On the market Parenchymal Probe 4F426012571ICP3STXMOn 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