Ventricular Probe 8F
Ref ICP.1.08.01Model ICP.1.ST
Active
CE MDR
Valid until
20 Mar 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426012571ICP1STXB 04260125713728 | Date11 Nov 2025 | StatusActive |
Certificates
- 1000265951 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 23 Oct 2025
- Expires
- 22 Oct 2030
- 1000265927 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 23 Oct 2025
- Expires
- 20 Mar 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ventricular Probe Standard
- Model / Reference
- ICP.1.ST, ICP.1.08.01
- Primary DI / UDI-DI
- 04260125713728
- Basic UDI-DI
- 426012571ICP1STXB
- EMDN Code
- A0601010402, N010399, Z12039001
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000000008
Other devices from Spiegelberg GmbH & Co. KG
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