Parenchymal Probe 4F with Cranial Bolt
by Spiegelberg GmbH & Co. KG EUDAMED
Active
Ref ICP.3.04.03, ICP.3.04.01Model ICP.3.ST
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426012571ICP3STXM | Date11 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000210544 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 3 Mar 2025
- Expires
- 20 Mar 2029
- 1000265927 Issued
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 23 Oct 2025
- Expires
- 20 Mar 2029
Specification
- Trade Name
- Parenchymal Probe 4F with Cranial BoltParenchymal Probe 4F
- Device Name
- Parenchymal Probe
- Model / Reference
- ICP.3.ST, ICP.3.04.03, ICP.3.04.01
- Primary DI / UDI-DI
- 04260125713834, 04260125713810
- Basic UDI-DI
- 426012571ICP3STXM
- EMDN Code
- Z12039001 Intracranial pressure measuring systems
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000000008
Other devices from Spiegelberg GmbH & Co. KG
Properties
Show properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No