Identity
- Trade Name
- Flowmaster EUDAMEDFlowmaster NS FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- Flowmaster EUDAMED
- Model / Reference
- U1-1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717775954828 EUDAMEDFDA UDI
- Basic UDI-DI
- 87177759500U1HE EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- Z121605 UROFLOWMETERS EUDAMED
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Flowmaster by Laborie Medical Technologies Corp. — Class I — 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 | 87177759500U1HE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED 0e09433b-e436-497e-ab86-19d19184979f 61 fields · synced Jul 16, 2026
- FDA UDI 75eb0bac-0d3d-4ea8-bd60-80e0f5d0ef26 32 fields · synced May 22, 2026