Identity
- Trade Name
- MEDIPLUS EUDAMED
- Device Name
- 60 % Latex Foley Balloon Catheter - Male - U201823 EUDAMED
- Model / Reference
- U201823 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G574U2018230 EUDAMED
- Basic UDI-DI
- B-G574U2018230 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Mediplus by Shree Umiya Surgical Pvt. Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
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-G574U2018230 | 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 704bc2f3-0e4f-4fd1-9707-cead8bbf1f1e 61 fields · synced Jul 16, 2026