Blood transfusion sets
by Sunrise Medical Co., Ltd. 8 variants
Ref BT01/150FModel BT01,BT02
Active
CE MDR
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/MDR | Number697565568BT01/150F26 06975655682106 | Date28 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Blood transfusion setsPrzyrzad do przetaczania krwi
- Device Name
- Disposable Blood Transfusion Sets
- Model / Reference
- BT01/150F, BT01, BT02
- Primary DI / UDI-DI
- 06975655682106
- Basic UDI-DI
- 697565568BT01/150F26, 697565568BT01QV
- EMDN Code
- A03010102 Infusion controllers with filter (also transfusion controllers)
- Device Class
- Class IIa
- EU market of registration
- GermanyPoland
Manufacturer details
- EUDAMED SRN
- CN-MF-000029852
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Sunrise Medical Co., Ltd.
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