Ventricular Drainage Catheter 8F with Cranial Bolt
Ref NKT.1.08.02, NKT.1.08.01, EVD30.010.01Model NKT.1.ST
Active
CE MDR CE MDD
Valid until
20 Mar 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number426012571NKT1ST53 | Date11 Nov 2025 | StatusActive |
| European Union | CE/MDR | Number426012571NKT1ST53 | Date11 Nov 2025 | StatusActive |
Certificates
- 1000216002 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 13 Mar 2025
- Expires
- 12 Mar 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- Withdrawn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/MDD, CE/MDR Active
Specification
- Trade Name
- Ventricular Drainage Catheter 8F with Cranial BoltVentricular Drainage Catheter 8F
- Device Name
- Ventricular Drainage Catheter Standard
- Model / Reference
- NKT.1.ST, NKT.1.08.02, NKT.1.08.01, EVD30.010.01
- Primary DI / UDI-DI
- 04260125713872, 04260125713865, 04260125710178
- Basic UDI-DI
- 426012571NKT1ST53, B-04260125710178
- EMDN Code
- A0601010402, N010399
- 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