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Positrace
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1870C-003Ref 1870-030Ref 1870C-004Ref 1870C-005
Identity
- Trade Name
- POSITRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDPOSITRACE RTL, ADULT DIAPHORIC ECG ELECTRODE FDA UDIPOSITRACE ADULT DIAPHORETIC ECG ELECTRODE FDA UDI
- Model / Reference
- 1870C-003 EUDAMEDFDA UDI1870-030 EUDAMEDFDA UDI1870C-004 EUDAMEDFDA UDI1870C-005 EUDAMEDFDA UDI
- Description
- POSITRACE RTL, ADULT DIAPHORIC ECG ELECTRODE FDA UDIPOSITRACE ADULT DIAPHORETIC ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 1870C-003 FDA UDI1870-030 FDA UDI1870C-004 FDA UDI1870C-005 FDA UDI
- Primary DI / UDI-DI
- 10653405059202 EUDAMEDFDA UDI10653405004523 EUDAMEDFDA UDI10653405059219 EUDAMEDFDA UDI10653405059226 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405059205 EUDAMED00653405004526 EUDAMED00653405059212 EUDAMED00653405059229 EUDAMED
- 510(k) Number
- K091856 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
Positrace by Conmed Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
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- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- 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 (12)
- EUDAMED 822de39e-d041-4894-a55b-7cf98a1d457d 61 fields · synced Jul 28, 2026
- EUDAMED cf1a0833-228a-4e06-b71e-7637355c65c1 61 fields · synced May 17, 2026
- EUDAMED 43229080-ce96-4e2c-acb6-06d3b957da3b 61 fields · synced May 17, 2026
- EUDAMED 37a08998-9bdf-4ad9-9fb0-c849ace73922 61 fields · synced May 18, 2026
- FDA UDI 713bfaf8-0e1a-4954-8232-ccf2f29df590 37 fields · synced May 30, 2026
- FDA UDI 54924f1c-ff4f-4ece-9f1d-23c98e9d47cd 37 fields · synced May 30, 2026
- FDA UDI d5c9232d-edaf-4f1d-b32c-ff35a3d237a0 37 fields · synced May 30, 2026
- FDA UDI 016ecfb6-1574-4eb9-982e-f11002b359ee 37 fields · synced May 30, 2026
- EUDAMED 01d51116-b491-4f39-a8b0-0776f12ede24 61 fields · synced Jun 20, 2026
- EUDAMED e903c05a-1d05-433a-bc10-1cbf04ac4783 61 fields · synced Jul 10, 2026
- EUDAMED 7762c128-0b0b-4616-b2a0-f042eed6a619 61 fields · synced Jul 14, 2026
- EUDAMED 9409afec-17d0-4d0d-8eb9-2c83813d6a62 61 fields · synced Jul 28, 2026