Identity
- Trade Name
- ProSeal NFV Hi-Flo Valve EUDAMED
- Device Name
- CSTD and Administration Devices EUDAMED
- Model / Reference
- 422150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299132157 EUDAMED
- Basic UDI-DI
- 88592991B014UD EUDAMED
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
ProSeal NFV Hi-Flo Valve by Epic International (Thailand) Co., Ltd. — Class I — 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 | 88592991B014UD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 56fa6af3-051f-4201-a6a9-26a6c5506192 61 fields · synced Oct 6, 2026