Identity
- Trade Name
- UROMIC Harmony EUDAMEDFDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- UROMIC EUDAMEDThe UROMIC Harmony is one of MMT's (MEDKONSULT medical technology s.r.o.) Urodynamic family of medical devices. The UROMIC Harmony (FU3000) is a small wireless urodynamic measuring system which can be operated as a small standalone measuring system or can be a wireless extension of the larger UROMIC Melody (FU4000) or UROMIC Symphony (FU5000) urodynamic systems. FDA UDI
- Model / Reference
- FU3000 EUDAMEDFDA UDI
- Description
- The UROMIC Harmony is one of MMT's (MEDKONSULT medical technology s.r.o.) Urodynamic family of medical devices. The UROMIC Harmony (FU3000) is a small wireless urodynamic measuring system which can be operated as a small standalone measuring system or can be a wireless extension of the larger UROMIC Melody (FU4000) or UROMIC Symphony (FU5000) urodynamic systems. FDA UDI
Identifiers
- Catalog Number
- FU3000 FDA UDI
- Primary DI / UDI-DI
- 08594211570145 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 Harmony 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MEDKONSULT medical technology s.r.o.
- EUDAMED SRN
- CZ-MF-000016193
Sources (2)
- EUDAMED acadf6cd-b834-4cc6-b722-8a978671f112 61 fields · synced Jul 29, 2026
- FDA UDI ad6596a9-253c-44d6-9eb0-c75a9ab0aa9f 35 fields · synced May 30, 2026