Identity
- Trade Name
- Aquarius Urodynamic System EUDAMEDAquarius LT FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- Aquarius Urodynamic System EUDAMED
- Model / Reference
- AQS1000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825003513 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00627825003513 EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- Z12160401 URODYNAMICS SYSTEMS EUDAMED
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class IIa 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
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
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
Yes
FDA UDI
Aquarius Urodynamic System by Laborie Medical Technologies Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00627825003513 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 a19e3597-2f5d-49be-98fd-d1706262e277 61 fields · synced Jun 18, 2026
- FDA UDI 006bbe4c-c307-4fef-b424-2de46ba67568 32 fields · synced May 29, 2026