Identity
- Device Name
- Sterile INFUSION SET EUDAMED
- Model / Reference
- Sterile INFUSION SET EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0145 EUDAMED
- Basic UDI-DI
- B-0145 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile INFUSION SET by Maramco for international trade — 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-0145 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maramco for international trade
- EUDAMED SRN
- EG-MF-000021419
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (1)
- EUDAMED bbf8f8e8-c622-40dd-b6d6-607fa1fb15e5 61 fields · synced Oct 6, 2026