Identity
- Trade Name
- Tubing Flowsensors EUDAMEDTransonic FDA UDI
- Generic Name
- Invasive vascular ultrasound system FDA UDI
- Device Name
- Flowsensors EUDAMED
- Model / Reference
- Flowsensors EUDAMEDH6XL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00877466000604 EUDAMED08774660000602 FDA UDI
- Basic UDI-DI
- 087746600HQHSSELE EUDAMED
- 510(k) Number
- K872048 FDA UDI
- FDA Product Code
- DPW FDA UDI
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
- GMDN Term
- Invasive vascular ultrasound system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2100 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
Ethylene Oxide FDA UDI
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 | 087746600HQHSSELE | 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 8ceadcb7-6cbc-4bce-a218-05d7fcdcb309 61 fields · synced Jun 17, 2026
- FDA UDI cd18bc4b-9817-4679-a26a-39d6342d164e 34 fields · synced May 30, 2026