Extracorporeal Circulation Kit
by Di̇sposet Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 304 variants
Ref 950-2022, 930-2001, 710-201002-000, 960-432120-000, DS-EL090-MM, DS-EL200-MM
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number86810495TF-08NS | Date13 Mar 2023 | StatusActive |
| European Union | CE/MDR | Number86810495TF-08NS | Date13 Mar 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Trade Name
- Breathing Circuits,Corrugated,Pediatric,,w/Extension Line, w/heatedDisposet
- Device Name
- Extracorporeal Circulation KitHeated Breathing CircuitsPressure LineExtension LineCardioplegia SetBreathing circuit, heated
- Model / Reference
- 950-2022, 930-2001, 710-201002-000, 960-432120-000, DS-EL090-MM, DS-EL200-MM
- Primary DI / UDI-DI
- 08681049502100, 08681049502025, 08681049500519, 08681049543912, 08698915591755, 08681049535016
- Basic UDI-DI
- 86810495TF-08NS, 86810495TF-11NF, B-08681049543912, B-08698915591755, B-08681049535016, B-08681049502025, B-08681049500519
- EMDN Code
- C03010101, C030102, R020107, A03020102, A03020199
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000018945
Other devices from Di̇sposet Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
See all devices from Di̇sposet Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No