Identity
- Device Name
- infusion set EUDAMED
- Model / Reference
- IVDM018-LS EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6971077613988AU EUDAMEDD-69710776138349Y EUDAMED
- Basic UDI-DI
- B-6971077613988AU EUDAMEDB-69710776138349Y EUDAMED
- EMDN Code
- A03040101 KITS FOR CONTINUOUS SUBCUTANEOUS INSULIN INFUSION EUDAMEDA03010101,A03040101,A03040102 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Latvia 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-6971077613988AU | 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 (2)
- EUDAMED 4cc5242f-5eb6-4e77-8a31-c0f4a084bcc3 61 fields · synced Oct 6, 2026
- EUDAMED 7ee51c86-35cc-404d-943b-14ed97f962c0 61 fields · synced May 19, 2026