Identity
- Trade Name
- EVA Container EUDAMED
- Device Name
- EVA Container EUDAMED
- Model / Reference
- EVA Container EUDAMEDJT-EYO-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955356125031 EUDAMED
- Basic UDI-DI
- 69553561EVAYOWD EUDAMED
- Direct Marketing DI
- 16955356125031 EUDAMED
- EMDN Code
- A080299 INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
EVA Container by Gemtier Medical (Shanghai) Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69553561EVAYOWD | Class I | Active |
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Manufacturer
- Manufacturer
- Gemtier Medical (Shanghai) Inc.
- EUDAMED SRN
- CN-MF-000003835
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3bc40df7-dff5-418b-9e2c-c2da0eb46c18 61 fields · synced Aug 3, 2026