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Nikotrace
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 6559Model 0515Ref 6500Ref 3040Ref 3014Ref 4039Ref 6550Ref 3016Ref 3015Ref 6535Ref 3015-3S
Identity
- Trade Name
- NIKOTRACE EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECG Electrodes EUDAMEDFDA UDIRepositionable ECG Electrodes FDA UDI
- Model / Reference
- 3016 EUDAMEDFDA UDI4039 EUDAMEDFDA UDI6559 EUDAMEDFDA UDI3014 EUDAMEDFDA UDI6535 EUDAMEDFDA UDI3015-3S EUDAMEDFDA UDI6550 EUDAMEDFDA UDI6500 EUDAMEDFDA UDI3015 EUDAMEDFDA UDI3040 EUDAMEDFDA UDI0515 EUDAMED6560 FDA UDI
- Description
- ECG Electrodes FDA UDIRepositionable ECG Electrodes FDA UDI
Identifiers
- Catalog Number
- 6560 FDA UDI3016 FDA UDI4039 FDA UDI6559 FDA UDI3014 FDA UDI6535 FDA UDI3015-3S FDA UDI6550 FDA UDI6500 FDA UDI3015 FDA UDI3040 FDA UDI
- Primary DI / UDI-DI
- 00853512006882 EUDAMED00853512006851 EUDAMED00853512006950 EUDAMED00853512006813 EUDAMED00853512006905 EUDAMED00853512006875 EUDAMED00853512006844 EUDAMED00853512006820 EUDAMED00853512006868 EUDAMED00853512006837 EUDAMED10853512006896 FDA UDI10853512006841 FDA UDI10853512006902 FDA UDI10853512006889 FDA UDI10853512006810 FDA UDI10853512006865 FDA UDI10853512006834 FDA UDI10853512006872 FDA UDI10853512006858 FDA UDI10853512006827 FDA UDI10853512006957 FDA UDI
- Basic UDI-DI
- 0853512006ECGELECTRODESAJ EUDAMED
- Unit of Use DI
- 10853512006889 EUDAMED10853512006858 EUDAMED10853512006957 EUDAMED10853512006810 EUDAMED10853512006902 EUDAMED10853512006872 EUDAMED10853512006841 EUDAMED10853512006827 EUDAMED10853512006865 EUDAMED10853512006834 EUDAMED
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Electrocardiographic electrode, single-use
Nikotrace by Nikomed Usa Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- 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 Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nikomed Usa Inc
Sources (21)
- FDA UDI 1cc1ddf3-17c1-40f4-ad2b-415e7fbcb3aa 36 fields · synced Sep 17, 2026
- FDA UDI 6ee5cbfe-4447-4dba-9ad2-705e3197f70b 36 fields · synced May 29, 2026
- FDA UDI d528cff7-0228-4c30-b1d7-3de4956d6c73 36 fields · synced May 29, 2026
- FDA UDI e6b3d5bc-250e-42ad-bf45-8e228637afde 36 fields · synced May 30, 2026
- FDA UDI 8962079c-23f1-4b7c-ae8a-a3f208fed491 36 fields · synced May 30, 2026
- FDA UDI 023d10af-9abc-445a-bf97-2d4e2b7307dd 36 fields · synced May 30, 2026
- FDA UDI 976a83e9-c27c-4ed1-952a-0543dc39eebe 36 fields · synced May 30, 2026
- FDA UDI 0b3d365c-5abb-4857-a202-ae0915e81528 36 fields · synced May 30, 2026
- FDA UDI d5672932-963d-46bf-9613-7ce61e474e71 36 fields · synced May 30, 2026
- FDA UDI f420b8ba-9c17-44d8-ae48-90f428e81944 36 fields · synced May 30, 2026
- FDA UDI b277e326-ee8a-4ff6-aa6d-bc31823c7bcb 36 fields · synced May 30, 2026
- EUDAMED c9816465-64d6-49c3-93b6-b1352da39378 61 fields · synced Jul 9, 2026
- EUDAMED abdcab6a-c957-4186-a4ff-52020ecaf34c 61 fields · synced Jul 10, 2026
- EUDAMED 7b352c51-6352-44d3-b5f8-8cd6b8c2b418 61 fields · synced Jul 14, 2026
- EUDAMED a600d924-7b0e-4e84-b7dc-4739a736124b 61 fields · synced Jul 19, 2026
- EUDAMED 1e3257a6-098a-4c3b-81bf-fa8001ac0343 61 fields · synced Jul 20, 2026
- EUDAMED e4d8d8fc-1a93-4a32-ba27-802a775bbc96 61 fields · synced Jul 20, 2026
- EUDAMED 784fbe2d-6fab-49cd-9606-a08cdf4a28c7 61 fields · synced Jul 23, 2026
- EUDAMED e4b6daa2-289f-4a77-8a6b-3739805aa42a 61 fields · synced Jul 26, 2026
- EUDAMED a280d079-3fd3-4fe2-b9ab-e48708298f81 61 fields · synced Jul 26, 2026
- EUDAMED 8e01a072-ffae-4328-919c-dd75855ab546 61 fields · synced Sep 17, 2026