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H4FX Clamp-on Tubing Flowsensors
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref H4FXModel HD03
Identity
- Trade Name
- H4FX Clamp-on Tubing Flowsensors EUDAMEDTransonic FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- HD03 EUDAMED
- Model / Reference
- HD03 EUDAMEDH4FX EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00877466000451 EUDAMEDFDA UDI
- Basic UDI-DI
- 087746600HD03ST6Z EUDAMED
- 510(k) Number
- K960817 FDA UDI
- FDA Product Code
- MQS FDA UDI
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5820 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
H4FX Clamp-on Tubing Flowsensors by Transonic Systems 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 | 087746600HD03ST6Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Transonic Systems Inc.
- EUDAMED SRN
- US-MF-000008784
- Authorised Representative
- Transonic Europe BV NL-AR-000004627
Sources (2)
- EUDAMED 8defd634-725a-4f34-ab84-a1ed4e5977ab 61 fields · synced Jul 27, 2026
- FDA UDI 561200cf-2557-4d43-afab-46e577271a87 33 fields · synced May 30, 2026