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Softrace
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2320-003Ref 2330C-003Ref 2310-003Ref 2331C-003Ref 2350-005Ref 2320C-003Ref 2331-003Ref 2321-003Ref 2350C-005Ref 2330-003
Identity
- Trade Name
- SOFTRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile EUDAMEDSOFTRACE SMALL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE, NEONATAL/PEDIATRIC ECG ELECTRODE FDA UDISOFTRACE LIMB BAND, NEONATAL/PEDIATRIC ECG ELECTRODE FDA UDISOFTRACE MEDIUM RTL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE LARGE REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE MEDIUM REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE SMALL RTL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE LARGE RTL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE MEDIUM RTL, NEONATAL/PEDIATRIC ECG ELECTRODE FDA UDI
- Model / Reference
- 2320-003 EUDAMED2330C-003 EUDAMEDFDA UDI2310-003 EUDAMEDFDA UDI2331C-003 EUDAMEDFDA UDI2350-005 EUDAMEDFDA UDI2320C-003 EUDAMEDFDA UDI2331-003 EUDAMEDFDA UDI2321-003 EUDAMEDFDA UDI2350C-005 EUDAMEDFDA UDI2330-003 EUDAMEDFDA UDI00602026000 FDA UDI
- Description
- SOFTRACE SMALL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE, NEONATAL/PEDIATRIC ECG ELECTRODE FDA UDISOFTRACE LIMB BAND, NEONATAL/PEDIATRIC ECG ELECTRODE FDA UDISOFTRACE MEDIUM RTL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE LARGE REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE MEDIUM REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE SMALL RTL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE LARGE RTL REPOSITIONABLE ECG ELECTRODE FDA UDISOFTRACE MEDIUM RTL, NEONATAL/PEDIATRIC ECG ELECTRODE FDA UDI
Identifiers
- Catalog Number
- 6020-260 FDA UDI2331-003 FDA UDI2310-003 FDA UDI2321-003 FDA UDI2330C-003 FDA UDI2350-005 FDA UDI2330-003 FDA UDI2320C-003 FDA UDI2350C-005 FDA UDI2331C-003 FDA UDI
- Primary DI / UDI-DI
- 10653405039006 EUDAMEDFDA UDI10653405055969 EUDAMEDFDA UDI30653405038973 EUDAMEDFDA UDI30653405064132 EUDAMEDFDA UDI10653405052937 EUDAMEDFDA UDI10653405055976 EUDAMEDFDA UDI30653405038997 EUDAMEDFDA UDI30653405038980 EUDAMEDFDA UDI10653405052951 EUDAMEDFDA UDI10653405033196 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408541DB EUDAMED
- Unit of Use DI
- 00653405039009 EUDAMED00653405055962 EUDAMED00653405038972 EUDAMED00653405064131 EUDAMED00653405052930 EUDAMED00653405055979 EUDAMED00653405038996 EUDAMED00653405038989 EUDAMED00653405052954 EUDAMED00653405033199 EUDAMED
- 510(k) Number
- K991105 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
Softrace by Conmed Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 (30)
- EUDAMED 5a8d1cff-cb2d-4531-8275-03ae0a0f32d8 61 fields · synced Sep 18, 2026
- EUDAMED a63e0357-e6ad-4857-bd4e-f4d429535c8e 61 fields · synced May 16, 2026
- EUDAMED 14ff6574-5225-4fda-84f6-1c0b6e04116e 61 fields · synced May 17, 2026
- EUDAMED d6680cac-be4c-4dc1-9f46-bc1f99a5cca5 61 fields · synced May 17, 2026
- EUDAMED 20d3f380-a0fb-412d-b3ab-e6dfa8b7df66 61 fields · synced May 17, 2026
- EUDAMED 78981d71-5f9c-4b8e-b783-ffeb2219cddd 61 fields · synced May 18, 2026
- EUDAMED 50dfc1b7-6794-4e07-9dc4-57d99ab5e27f 61 fields · synced May 18, 2026
- EUDAMED c1a34dca-57cf-4193-93cb-9ae5cfbef367 61 fields · synced May 18, 2026
- EUDAMED ff25fe7d-7c62-4e1d-a4ac-ffced3278b44 61 fields · synced May 18, 2026
- EUDAMED ef781441-f66b-4643-a2c0-4c216819c572 61 fields · synced May 19, 2026
- FDA UDI 91a57bea-e3b9-49c2-bace-8cbbaca9f586 36 fields · synced May 29, 2026
- FDA UDI 36ae0702-7a3a-4bda-b75e-d93348296c14 36 fields · synced May 30, 2026
- FDA UDI 09b1655b-7965-4e65-b2dd-e5caa92b7c7e 36 fields · synced May 30, 2026
- FDA UDI 84750dc3-4a11-4e42-b1dd-af2a365eda5e 36 fields · synced May 30, 2026
- FDA UDI a9abce40-c4ba-4f91-b32a-f7632a68f226 36 fields · synced May 30, 2026
- FDA UDI 4d623af5-f12c-493c-a64a-9fc9738d288c 37 fields · synced May 30, 2026
- FDA UDI 13fecea0-6c62-4c39-b8df-444f63b99398 36 fields · synced May 30, 2026
- FDA UDI ff5a07ef-35fe-4fb9-a845-0aa11aaa891b 36 fields · synced May 30, 2026
- FDA UDI 25543c68-e087-4865-9d92-ab02aad8d2d1 37 fields · synced May 30, 2026
- FDA UDI fd88fe99-6917-4757-bacb-0cdd5378f780 36 fields · synced May 30, 2026
- EUDAMED 1e0fec6d-6818-4860-a6d8-e0748e62e953 61 fields · synced Jun 20, 2026
- EUDAMED e49a209c-1184-4ae8-80db-d1b67c2b3aab 61 fields · synced Jun 20, 2026
- EUDAMED 1af75e8e-3082-4294-84ce-9d6fb70b81b9 61 fields · synced Jul 9, 2026
- EUDAMED ecd5c889-f660-4da3-a4dd-31348f058bb9 61 fields · synced Jul 10, 2026
- EUDAMED e4cc6678-5552-4651-bb6a-835c912c3ac1 61 fields · synced Jul 19, 2026
- EUDAMED d22b35cb-dc1f-4bf3-98fd-c59ebb698630 61 fields · synced Jul 26, 2026
- EUDAMED e5dcbea0-f2a0-473f-b2d6-eb50e09a9ac0 61 fields · synced Jul 27, 2026
- EUDAMED 91d0df4a-949d-4ad1-81f7-0327fdcc9656 61 fields · synced Jul 29, 2026
- EUDAMED f5bbe857-d8dd-4836-b30b-8a35ea5c1ea8 61 fields · synced Sep 17, 2026
- EUDAMED 4df37ff7-845f-44e5-bd24-d5cb866470ef 61 fields · synced Sep 18, 2026