Identity
- Trade Name
- Closed System Bag Converter EUDAMED
- Device Name
- Empty Fluid Container EUDAMED
- Model / Reference
- 426120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299136124 EUDAMED
- Basic UDI-DI
- 88592991B017UK EUDAMED
- EMDN Code
- A080299 INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Category: Intravenous administration bag/bottle
Closed System Bag Converter by Epic International (Thailand) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous administration bag/bottle.
- Bag for enzyme replacement therapy — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- SECURE® — METRIX COMPANY, THE · Class II
- EVA TPN Bags — Valmed Corp. · Class II
- Parenteral nutrition bag — VALMED SRL · Class IIa
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 | 88592991B017UK | 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 f59074e8-78bc-41fc-967a-9b22ffc7b7b4 61 fields · synced Sep 17, 2026