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Organization name
UDI-DI code
Reference / catalog number

Pressure Monitor — Class IIa MDR by Spiegelberg GmbH & Co. KG

MD Atlas
Spiegelberg GmbH & Co. KG

EUDAMED last updated this device on Apr 23, 2026

Pressure Monitor

426012571MON1ST4Q

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Spiegelberg GmbH & Co. KG
UDI-DI code: 04260125713841
Reference / catalog number: MON.1.00.01

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Manufacturer information

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

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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: Pressure Monitor
UDI-DI code: 04260125713841
Basic UDI-DI: 426012571MON1ST4Q
Reference / catalog number: MON.1.00.01
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The Pressure Monitor in combination with Spiegelberg ICP-probes and Spiegelberg IAP-probes serves to observe the intracranial (ICP) respectively intraabdominal pressure (IAP).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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

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