Identity
- Device Name
- INFUSION SET EUDAMED
- Model / Reference
- IVDM018B EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6971077617429AF EUDAMED
- Basic UDI-DI
- B-6971077617429AF EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Set by Zibo Eastmed Healthcare Products Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-6971077617429AF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zibo Eastmed Healthcare Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000032259
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 9359aea1-bcd0-41a2-a1fc-f909aae4749c 61 fields · synced Jun 18, 2026