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HD03 Patient-less Measurement Module
EUDAMEDClass IIa (EU MDR)
Ref PMM Model HD03
Identity
- Trade Name
- HD03 Patient-less Measurement Module EUDAMED
- Device Name
- HD03 EUDAMED
- Model / Reference
- HD03 EUDAMEDPMM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00877466008044 EUDAMED
- Basic UDI-DI
- 087746600HD03ST6Z 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
HD03 Patient-less Measurement Module 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 | 087746600HD03ST6Z | 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 af3cbe56-3086-403f-be19-9a0e240ad95b 61 fields · synced Jun 20, 2026