Identity
- Device Name
- Disposable Blood Transfusion Sets EUDAMED
- Model / Reference
- 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975266040026 EUDAMED
- Basic UDI-DI
- B-16975266040026 EUDAMED
- EMDN Code
- A03010102 INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Blood Transfusion Sets by Shandong Qinkai Medical Industry Co.Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16975266040026 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Qinkai Medical Industry Co.Ltd
- EUDAMED SRN
- CN-MF-000030489
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 0b0b8615-40b5-4485-a018-ebdf3b071187 61 fields · synced Jun 19, 2026