Identity
- Trade Name
- MEDIPLUS EUDAMED
- Device Name
- 60 % Latex Foley Balloon Catheter - Male - U2018213 EUDAMED
- Model / Reference
- U2018213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G574U20182130 EUDAMED
- Basic UDI-DI
- B-G574U20182130 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
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-G574U20182130 | 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 3fdfe918-96ee-4bf9-bf69-4c02ed903403 61 fields · synced Jul 30, 2026