Identity
- Trade Name
- UROMIC Melody EUDAMEDFDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- UROMIC EUDAMEDThe UROMIC Melody is one of MMT's (MEDKONSULT medical technology s.r.o.) Urodynamics family of medical devices. The UROMIC Melody (FU4000) is a small compact urodynamic measuring system for complete urodynamic examinations. FDA UDI
- Model / Reference
- FU4000 EUDAMEDFDA UDI
- Description
- The UROMIC Melody is one of MMT's (MEDKONSULT medical technology s.r.o.) Urodynamics family of medical devices. The UROMIC Melody (FU4000) is a small compact urodynamic measuring system for complete urodynamic examinations. FDA UDI
Identifiers
- Catalog Number
- FU4000 FDA UDI
- Primary DI / UDI-DI
- 08594211570152 EUDAMEDFDA UDI
- Basic UDI-DI
- 859421157UROMICUZ EUDAMED
- EMDN Code
- Z12160401,Z121605 EUDAMED
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
UROMIC Melody by MEDKONSULT medical technology s.r.o. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 859421157UROMICUZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MEDKONSULT medical technology s.r.o.
- EUDAMED SRN
- CZ-MF-000016193
Sources (2)
- EUDAMED cf5c2508-1838-4594-b1ad-308bb3a1306f 61 fields · synced Jul 12, 2026
- FDA UDI 8e6533dc-b997-402a-b3fc-8658f3769be0 35 fields · synced May 30, 2026