Identity
- Trade Name
- Fluent Fluid Management System EUDAMEDFluent Console FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Device Name
- Fluent Fluid Management System EUDAMEDThe Fluent®Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators FDA UDI
- Model / Reference
- FLT-100 EUDAMEDFDA UDI
- Description
- The Fluent®Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators FDA UDI
Identifiers
- Catalog Number
- FLT-100 FDA UDI
- Primary DI / UDI-DI
- 15420045508552 EUDAMEDFDA UDI
- Basic UDI-DI
- B-15420045508552 EUDAMED
- 510(k) Number
- K180825 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1700 FDA UDI884.1690 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Fluent Fluid Management System by Hologic Inc. — Class IIb — 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-15420045508552 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED 3bff334c-b940-4d60-8936-140f51271e00 61 fields · synced Jul 11, 2026
- FDA UDI 83225aad-96e2-42be-9998-b49103adbdaa 37 fields · synced May 30, 2026