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Infusion Workstation
EUDAMEDClass IIb (EU MDR)
Ref /Model XP-80, XP-80 PRO, AP-80, AP-80 PRO
Identity
- Device Name
- Infusion Workstation EUDAMED
- Model / Reference
- XP-80, XP-80 PRO, AP-80, AP-80 PRO EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802607381 EUDAMED
- Basic UDI-DI
- 69268026XP80000000000019Y EUDAMED
- EMDN Code
- Z12030306 INFUSION AND SYRINGE PUMP CONTROL SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Infusion Workstation by Medcaptain Medical Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69268026XP80000000000019Y | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7a241b11-895e-47c6-a334-7fd8f28d434f 61 fields · synced Jul 14, 2026