Identity
- Trade Name
- MEDIPLUS EUDAMED
- Device Name
- With Dial Flow Regulator - Infusion Set with Dial Flow Regulator, Adult with needle - T16012 EUDAMED
- Model / Reference
- T16012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G574T160120 EUDAMED
- Basic UDI-DI
- B-G574T160120 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Mediplus by Shree Umiya Surgical Pvt. 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-G574T160120 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shree Umiya Surgical Pvt. Ltd
- EUDAMED SRN
- IN-MF-000018008
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3e7de78d-fd5c-418d-9378-d64be17cc513 61 fields · synced Jul 13, 2026