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Fluent Pro Fluid Management System Procedure Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FLT-212S
by Hologic Inc
Identity
- Trade Name
- Fluent Pro Fluid Management System Procedure Kit EUDAMEDFluent Pro Procedure Kit FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Device Name
- Fluent Pro Fluid Management System Disposable Procedure Kit EUDAMEDThe Fluent Pro 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 liquid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators. FDA UDI
- Model / Reference
- FLT-212S EUDAMEDFDA UDI
- Description
- The Fluent Pro 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 liquid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators. FDA UDI
Identifiers
- Catalog Number
- FLT-212S FDA UDI
- Primary DI / UDI-DI
- 15420045516144 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSFLUENTDISPZN EUDAMED
- Direct Marketing DI
- 15420045516144 EUDAMED
- 510(k) Number
- K240886 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- A080201 INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE EUDAMED
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fluent Pro Fluid Management System Procedure Kit by Hologic Inc. — 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 | 54200455GSSFLUENTDISPZN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 90970f83-a2cb-467b-b7eb-c682248163d2 61 fields · synced Jun 18, 2026
- FDA UDI a659377c-ad97-44a0-9d5c-0a82b808d2b7 36 fields · synced May 29, 2026