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Disposable Autotransfusion System
EUDAMEDClass IIb (EU MDR)
Ref XH-1000, XH-2000, XH-3000, XH-4000
Identity
- Trade Name
- Disposable Autotransfusion System EUDAMED
- Device Name
- Disposable Autotransfusion System EUDAMED
- Model / Reference
- XH-1000, XH-2000, XH-3000, XH-4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-XH96 EUDAMED
- Basic UDI-DI
- B-XH96 EUDAMED
- EMDN Code
- B0499 AUTOTRANSFUSION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 Autotransfusion System by Beijing ZKSK Technology Co., Ltd — Class IIb — 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-XH96 | Class IIb | 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 (2)
- EUDAMED 53caa723-fd45-4769-ad88-b54c5951b6e4 61 fields · synced Jun 19, 2026
- EUDAMED 53caa723-fd45-4769-ad88-b54c5951b6e4-1 61 fields · synced Jun 10, 2026