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Cleartrace
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1700-030Ref 2700-003Ref 1700-050Ref 1700C-010Ref 1700C-003Ref 1700C-050Ref 2700-030
Identity
- Trade Name
- CLEARTRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDCLEARTRACE ADULT ECG ELECTRODE FDA UDICLEARTRACE 2 ADULT ECG ELECTRODE FDA UDICLEARTRACE RTL ADULT ECG ELECTRODE FDA UDI
- Model / Reference
- 1700-030 EUDAMEDFDA UDI2700-003 EUDAMEDFDA UDI1700-050 EUDAMEDFDA UDI1700C-010 EUDAMEDFDA UDI1700C-003 EUDAMEDFDA UDI1700C-050 EUDAMEDFDA UDI2700-030 EUDAMEDFDA UDI
- Description
- CLEARTRACE ADULT ECG ELECTRODE FDA UDICLEARTRACE 2 ADULT ECG ELECTRODE FDA UDICLEARTRACE RTL ADULT ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 1700-030 FDA UDI2700-030 FDA UDI1700-050 FDA UDI1700C-050 FDA UDI2700-003 FDA UDI1700C-003 FDA UDI1700C-010 FDA UDI
- Primary DI / UDI-DI
- 10653405004264 EUDAMEDFDA UDI10653405005346 EUDAMEDFDA UDI10653405055617 EUDAMEDFDA UDI10653405063070 EUDAMEDFDA UDI10653405059141 EUDAMEDFDA UDI10653405059165 EUDAMEDFDA UDI30653405005364 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405004267 EUDAMED00653405005349 EUDAMED00653405055610 EUDAMED00653405063073 EUDAMED00653405059144 EUDAMED00653405059168 EUDAMED00653405005363 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
MR Safe FDA UDI
Category: Electrocardiographic electrode, single-use
Cleartrace 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 (21)
- EUDAMED 3422076d-e0c5-49db-83a9-fc3725f759c4 61 fields · synced Jul 31, 2026
- EUDAMED dc046cf3-883c-436d-b313-912728abce59 61 fields · synced May 11, 2026
- EUDAMED 1e54068d-7889-4d61-ad1b-65c16b7cb96d 61 fields · synced May 16, 2026
- EUDAMED 340c29be-aeac-42c0-843b-b9e9fd43a05f 61 fields · synced May 16, 2026
- EUDAMED 59adb657-348c-48fa-a146-cf81c1a2f9b3 61 fields · synced May 17, 2026
- EUDAMED 235b24a9-cd68-4b47-a956-8014489a8e72 61 fields · synced May 17, 2026
- EUDAMED 275ecd5c-2780-4b16-b567-7c5028077662 61 fields · synced May 18, 2026
- FDA UDI 8ae325af-d30f-41c0-868a-b025aecf0d07 37 fields · synced May 29, 2026
- FDA UDI 2399ecdd-0eac-44dd-ba4f-c28a5959d2bd 37 fields · synced May 30, 2026
- FDA UDI 4e79381f-3ab5-458c-892c-25158bbd3427 37 fields · synced May 30, 2026
- FDA UDI e8d17a71-c2ef-42e1-b46a-7233fd2a27ad 37 fields · synced May 30, 2026
- FDA UDI a3d54edf-eeb5-4bfe-91c2-f7fa689b3240 37 fields · synced May 30, 2026
- FDA UDI a51f5073-349c-4e1d-b567-7f85886ee58e 37 fields · synced May 30, 2026
- FDA UDI 19253659-02ba-436a-a5a4-29bcf8c3b62e 37 fields · synced May 30, 2026
- EUDAMED 1ff1d4ac-3d95-4ac8-a8d3-e82c3903273e 61 fields · synced Jul 11, 2026
- EUDAMED 15a7d3ae-36cd-4469-bf2b-71b70f846147 61 fields · synced Jul 13, 2026
- EUDAMED 92316356-3676-4b52-ba3b-e194eee77fe0 61 fields · synced Jul 14, 2026
- EUDAMED 5dfd6af0-ce01-4c73-8730-f96675ff5caa 61 fields · synced Jul 15, 2026
- EUDAMED c29d3913-9c1d-479f-b26f-40b144373071 61 fields · synced Jul 25, 2026
- EUDAMED da8094a2-4640-4e36-808a-0e8f42bcb354 61 fields · synced Jul 31, 2026
- EUDAMED 9e1ce115-0742-4629-9949-4682347db82c 61 fields · synced Jul 31, 2026