Palindrome™ Precision Chronic Catheter
Ref 8888145014PModel Palindrome™ Precision Chronic Catheter
Active
CE MDR
Valid until
25 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0197990B00000016KQ 30197990002884 | Date1 Jul 2026 | StatusActive |
Certificates
- G70 123034 0004 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 26 Jun 2026
- Expires
- 25 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Palindrome™ Precision Chronic Catheter, 8888145014P
- Primary DI / UDI-DI
- 30197990002884
- Basic UDI-DI
- 0197990B00000016KQ
- Direct Marketing DI
- 00197990002883
- EMDN Code
- F900202 Permanent hemodialysis catheters and kits
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000043425
- Authorised representative
- Mozarc Medical Ireland Ltd. IE-AR-000048547
Other devices from Mozarc Medical US LLC
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No