Identity
- Trade Name
- PCA-C100BS Patient Cable EUDAMEDQT ECG FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- PCA-C100 series Patient Cable EUDAMEDA reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the patient’s body for both diagnostic purposes. FDA UDI
- Model / Reference
- PCA-C100BS EUDAMEDFDA UDI
- Description
- A reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the patient’s body for both diagnostic purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872981589 EUDAMEDFDA UDI
- Basic UDI-DI
- 04719872980254VB EUDAMED
- Direct Marketing DI
- 04719872981589 EUDAMED
- 510(k) Number
- K200722 FDA UDI
- FDA Product Code
- DSA 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
- 870.2900 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
No
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
Category: Electrocardiographic lead set, reusable
PCA-C100BS Patient Cable by QT Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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 | 04719872980254VB | 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 8a2bce04-bab5-4772-b7fa-c7b2a8094f21 61 fields · synced Oct 6, 2026
- FDA UDI dfe41680-5f47-415c-9c27-a70e0840c56a 35 fields · synced May 30, 2026