Identity
- Trade Name
- INSTATRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDINSTATRACE ADULT ECG ELECTRODE FDA UDI
- Model / Reference
- 1590-003 EUDAMEDFDA UDI1590-005 EUDAMEDFDA UDI
- Description
- INSTATRACE ADULT ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 1590-005 FDA UDI1590-003 FDA UDI
- Primary DI / UDI-DI
- 10653405003762 EUDAMEDFDA UDI10653405003779 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405003765 EUDAMED00653405003772 EUDAMED
- 510(k) Number
- K963787 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 UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic electrode, single-use
Instatrace 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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- Medline — MEDLINE INDUSTRIES, 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 | 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 0eb25ef5-fe78-4ce9-a4e2-c94003796928 61 fields · synced Jul 29, 2026
- EUDAMED cfd273d0-adb3-4193-b3bc-cd3b0eae7985 61 fields · synced May 17, 2026
- FDA UDI 39575083-8eb2-4bdd-8b45-a19ee2059a62 37 fields · synced May 30, 2026
- FDA UDI 24a7b31c-ea15-48db-bd89-28e8414f4356 37 fields · synced May 30, 2026
- EUDAMED fc5ec2e4-fbd5-4f29-a6c9-3a39558cfb73 61 fields · synced Jul 10, 2026
- EUDAMED 30e538b8-fdd1-4aee-8c35-adfc7eedff11 61 fields · synced Jul 29, 2026