Identity
- Trade Name
- PCA-A400 Extension Cable EUDAMEDQT ECG FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- PCA-A400 Extension Cable EUDAMEDPCA-A400 ECG Extension cable is used to extend and transmit ECG signals from patients for general diagnostic evaluation by health care professionals. PCA-A400 Extension cable shall combine with QTM accessory. FDA UDI
- Model / Reference
- PCA-A400 EUDAMEDFDA UDI
- Description
- PCA-A400 ECG Extension cable is used to extend and transmit ECG signals from patients for general diagnostic evaluation by health care professionals. PCA-A400 Extension cable shall combine with QTM accessory. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872981350 EUDAMEDFDA UDI
- Basic UDI-DI
- 04719872981350VF EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PCA-A400 Extension Cable by QT Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 04719872981350VF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- QT Medical, Inc.
- EUDAMED SRN
- US-MF-000014384
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED fb7c60a1-af95-4fdb-b71e-4e11d29229b2 61 fields · synced Sep 17, 2026
- FDA UDI 31a27dc5-6288-4894-b54f-a4742f106a0e 34 fields · synced May 29, 2026