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Standard FlowXL Meter with AdvancedFlow Software
EUDAMEDClass IIa (EU MDR)
Ref HT520AFModel FlowXL Meter
Identity
- Trade Name
- Standard FlowXL Meter with AdvancedFlow Software EUDAMED
- Device Name
- FlowXL Meter EUDAMED
- Model / Reference
- FlowXL Meter EUDAMEDHT520AF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00877466006934 EUDAMED
- Basic UDI-DI
- 087746600FlowXL8F EUDAMED
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Standard FlowXL Meter with AdvancedFlow Software by Transonic Systems Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 087746600FlowXL8F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Transonic Systems Inc.
- EUDAMED SRN
- US-MF-000008784
- Authorised Representative
- Transonic Europe BV NL-AR-000004627
Sources (1)
- EUDAMED 33b78589-3878-422b-acb2-b5ab6730d3ec 61 fields · synced Jun 18, 2026