Split Stream Repair Kits
by Medical Components, Inc. United States EUDAMED
Ref SSAE
EMDN F9080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number00884908105MQ | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Tesio and Chronic Twinline Repair Kits
- Model / Reference
- SSAE
- Primary DI / UDI-DI
- 00884908165739
- Basic UDI-DI
- 00884908105MQ
- EMDN Code
- F9080 Dialysis devices - other accessories
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008230
- Authorised representative
- MPS Medical Product Service GmbH DE-AR-000005009
From the manufacturer
Manufacturer's product page: Split Stream®
Other devices from Medical Components, Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED b50fc560-acda-4c44-9b2d-15491160eb22