Identity
- Trade Name
- PCA 500+ EUDAMED
- Device Name
- Portable ECG system (QT ECG) EUDAMED
- Model / Reference
- QTERD100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872981855 EUDAMED
- Basic UDI-DI
- 471987298002QTERD001WH EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
Pca 500+ by QT Medical, 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 | 471987298002QTERD001WH | Class IIa | Active |
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Manufacturer
- Manufacturer
- QT Medical, Inc.
- EUDAMED SRN
- US-MF-000014384
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED fe61f1c4-d113-4704-9713-3235c6c09401 61 fields · synced Jun 19, 2026