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Vented Blood Administration Set, HiFlo Port, 195 cm
EUDAMEDClass IIa (EU MDR)
Ref 430150
Identity
- Trade Name
- Vented Blood Administration Set, HiFlo Port, 195 cm EUDAMED
- Device Name
- Administration Sets, Blood Transfusion Sets EUDAMED
- Model / Reference
- 430150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299116966 EUDAMED
- Basic UDI-DI
- 88592991B025UJ EUDAMED
- EMDN Code
- A03010102 INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS) EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vented Blood Administration Set, HiFlo Port, 195 cm by Epic International (Thailand) Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 88592991B025UJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Epic International (Thailand) Co., Ltd.
- EUDAMED SRN
- TH-MF-000012102
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 4930c387-fa23-40ba-8265-9a77cdc314a0 61 fields · synced Jun 19, 2026