Identity
- Trade Name
- Disposable Autotransfusion System EUDAMED
- Device Name
- Disposable Autotransfusion System EUDAMED
- Model / Reference
- XH-4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934415088336 EUDAMED
- Basic UDI-DI
- B-06934415088336 EUDAMED
- EMDN Code
- B0499 AUTOTRANSFUSION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Autotransfusion System by Beijing ZKSK Technology 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-06934415088336 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e0b357de-e4c6-4d13-80d0-334c265ad456 61 fields · synced Jun 19, 2026