Identity
- Trade Name
- EMPTY FULID CONTAINER EUDAMEDSMARTeZ Plus-General Infusion 50-50-60m EUDAMED
- Device Name
- EMPTY FLUID CONTAINER EUDAMEDElastomeric Pump EUDAMED
- Model / Reference
- A080299 EUDAMED471010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299171019 EUDAMED
- Basic UDI-DI
- 88592991B017UK EUDAMED88592991B001U4 EUDAMED
- EMDN Code
- A080299 INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMEDA05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Empty Fulid Container 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 | 88592991B017UK | Class I | 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 (2)
- EUDAMED e3b663ef-d857-4abc-86cf-1435606a55e9 61 fields · synced Oct 6, 2026
- EUDAMED 5cc8bdeb-d0e0-4b52-9178-ae98ec5e1eee 61 fields · synced Jul 19, 2026