Identity
- Trade Name
- PCA-A300 ECG Cable Converter IEC EUDAMED
- Device Name
- PCA-A300 ECG Cable Converter EUDAMED
- Model / Reference
- PCA-A300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872982081 EUDAMED
- Basic UDI-DI
- 04719872980933W6 EUDAMED
- Direct Marketing DI
- 04719872982081 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PCA-A300 ECG Cable Converter IEC by QT Medical, Inc. — Class I — 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 | 04719872980933W6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- QT Medical, Inc.
- EUDAMED SRN
- US-MF-000014384
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 874e362d-5e20-4a76-af1d-33496a2e28fb 61 fields · synced Jul 16, 2026