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Suretrace
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1800-003Ref 1800C-005Ref 1800C-003Ref 1800-030
Identity
- Trade Name
- SURETRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDSURETRACE RTL, ADULT ECG ELECTRODE FDA UDISURETRACE ADULT ECG ELECTRODE FDA UDI
- Model / Reference
- 1800-003 EUDAMEDFDA UDI1800C-005 EUDAMEDFDA UDI1800C-003 EUDAMEDFDA UDI1800-030 EUDAMEDFDA UDI
- Description
- SURETRACE RTL, ADULT ECG ELECTRODE FDA UDISURETRACE ADULT ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 1800C-003 FDA UDI1800-030 FDA UDI1800-003 FDA UDI1800C-005 FDA UDI
- Primary DI / UDI-DI
- 10653405004394 EUDAMEDFDA UDI10653405059189 EUDAMEDFDA UDI10653405059172 EUDAMEDFDA UDI10653405004417 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405004397 EUDAMED00653405059182 EUDAMED00653405059175 EUDAMED00653405004410 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
Suretrace 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 (12)
- EUDAMED d0dec943-f8e0-477f-8584-596a87fe3e56 61 fields · synced Jul 28, 2026
- EUDAMED 4f516a91-d20d-471e-b2e1-b8d808dc10c4 61 fields · synced May 18, 2026
- EUDAMED f4eb3916-a98e-4c76-a57c-c8fffe04056e 61 fields · synced May 18, 2026
- EUDAMED 87c7e38b-b592-480c-b4a2-c2230dc21207 61 fields · synced May 19, 2026
- FDA UDI 0e58d92d-9d1a-4987-957b-ccf3b72c38df 37 fields · synced May 30, 2026
- FDA UDI 71e7014a-4943-40bf-950d-bae5a61fa26d 37 fields · synced May 30, 2026
- FDA UDI b2005044-1fc5-40da-a6b6-b8e2b947505d 37 fields · synced May 30, 2026
- FDA UDI 47ac6ec6-aa05-4ca0-b70f-f9cb176b8853 37 fields · synced May 30, 2026
- EUDAMED b2977556-c527-4c72-a2cf-467e1605275f 61 fields · synced Jul 8, 2026
- EUDAMED 8db12ea2-62d6-4a80-b91f-ff9e8faf9d68 61 fields · synced Jul 9, 2026
- EUDAMED 4e61a558-f742-4b36-a091-e7e135cd9dec 61 fields · synced Jul 18, 2026
- EUDAMED e70bd4c0-1751-448b-b063-70692695af12 61 fields · synced Jul 28, 2026