Identity
- Trade Name
- MEDIPLUS EUDAMED
- Device Name
- 60 % Latex Foley Balloon Catheter - Female - U2018145 EUDAMED
- Model / Reference
- U2018145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G574U20181450 EUDAMED
- Basic UDI-DI
- B-G574U20181450 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - 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
Yes
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
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-G574U20181450 | 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 107c9579-9abf-4baa-a333-e70de61c448a 61 fields · synced Jul 9, 2026