Identity
- Trade Name
- Tubing Flowsensors EUDAMED
- Device Name
- Flowsensors EUDAMED
- Model / Reference
- Flowsensors EUDAMEDHS12XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00877466007344 EUDAMED
- Basic UDI-DI
- 087746600HQHSSELE 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
Tubing Flowsensors 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 | 087746600HQHSSELE | 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 76ec5dba-dd49-46bd-b7f6-16f09deba5d5 61 fields · synced Jun 19, 2026