Identity
- Trade Name
- DYNA/TRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDDYNA/TRACE ADULT ECG ELECTRODE FDA UDIDYNA/TRACE STRESS, ADULT DIAGNOSTIC ECG ELECTRODE FDA UDI
- Model / Reference
- 1550-005 EUDAMEDFDA UDI1500-001 EUDAMEDFDA UDI
- Description
- DYNA/TRACE ADULT ECG ELECTRODE FDA UDIDYNA/TRACE STRESS, ADULT DIAGNOSTIC ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 1500-001 FDA UDI1550-005 FDA UDI
- Primary DI / UDI-DI
- 10653405003724 EUDAMEDFDA UDI10653405003601 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405003727 EUDAMED00653405003604 EUDAMED
- 510(k) Number
- K991105 FDA UDI
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Category: Electrocardiographic electrode, single-use
Dyna/Trace by Conmed Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 084585408541DB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (6)
- EUDAMED 36b2d1b4-0a34-4a16-8440-1ae37e8e0acc 61 fields · synced Jul 31, 2026
- EUDAMED e629c60e-3fc8-43a7-b2a7-0f1709f1b1c5 61 fields · synced May 17, 2026
- FDA UDI de69dd34-43df-43ce-80a0-a9935dcb64de 37 fields · synced May 30, 2026
- FDA UDI 53f8b5fc-90ac-469f-9459-262812e70333 37 fields · synced May 30, 2026
- EUDAMED acc576be-1918-42d9-8689-cb5e53db658e 61 fields · synced Jun 18, 2026
- EUDAMED 10aa53a7-525d-466f-84d0-b193bd3911c7 61 fields · synced Jul 31, 2026