CONMED - Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile (38-404-…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- CONMED EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDECG STRIPPER, ADULT ECG ELECTRODE FDA UDI
- Model / Reference
- 38-404-1 EUDAMEDFDA UDI
- Description
- ECG STRIPPER, ADULT ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 38-404-1 FDA UDI
- Primary DI / UDI-DI
- 10653405005957 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405005950 EUDAMED
- 510(k) Number
- K960264 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 II FDA UDI
- Legislation / Framework
- MDR (REGULATION (EU) 2017/745 on medical devices) EUDAMED
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Electrocardiographic electrode, single-use
CONMED - Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile (38-404-… by Conmed Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 (2)
- EUDAMED 66 fields · synced May 30, 2026
- FDA UDI 200a59d9-2abd-4023-9cda-8e0d2fc9e0c3 37 fields · synced May 30, 2026