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Everyway
EUDAMEDFDA UDIClass I (EU MDR)
Ref KB5050Ref KF4080Ref KF25DRef KF40350Ref KF100180Ref KF110130Ref SGB50100Ref SG90100Ref CT-800Ref SGB5050Ref KF110180Ref SG50100Ref HC-893ARef KF200Ref KB50100Ref SG5050
Identity
- Trade Name
- Everyway EUDAMEDEveryway Medical EUDAMEDLifecare FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Cutaneous Electrode Pad EUDAMEDCervical Traction Device EUDAMEDConductive Garments EUDAMEDAnalytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) and connected to an appropriate parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), impedance pneumography (IP)]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small cup/disk with a conductive surface and may include a length of insulated connecting wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. FDA UDI
- Model / Reference
- KB5050 EUDAMEDKF4080 EUDAMEDKF25D EUDAMEDKF40350 EUDAMEDKF100180 EUDAMEDKF110130 EUDAMEDSGB50100 EUDAMEDSG90100 EUDAMEDCT-800 EUDAMEDSGB5050 EUDAMEDKF110180 EUDAMEDSG50100 EUDAMEDHC-893A EUDAMEDKF200 EUDAMEDKB50100 EUDAMEDSG5050 EUDAMEDHC-892A FDA UDI
- Description
- Analytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) and connected to an appropriate parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), impedance pneumography (IP)]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small cup/disk with a conductive surface and may include a length of insulated connecting wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871185674 EUDAMED04719871185667 EUDAMED04719871185629 EUDAMED04719871185742 EUDAMED04719871185698 EUDAMED04719871185803 EUDAMED04719871185735 EUDAMED04719871185810 EUDAMED04719871185124 EUDAMED04719871185711 EUDAMED04719871185766 EUDAMED04719871185728 EUDAMED04719871183335 EUDAMEDFDA UDI04719871185650 EUDAMED04719871185681 EUDAMED04719871185704 EUDAMED
- Basic UDI-DI
- 471987118-ELECTRODE-H5 EUDAMED471987118-TRACTION-23 EUDAMED471987118-GARMENTS-QT EUDAMED
- Direct Marketing DI
- 04719871185674 EUDAMED04719871185667 EUDAMED04719871185629 EUDAMED04719871185742 EUDAMED04719871185698 EUDAMED04719871185803 EUDAMED04719871185735 EUDAMED04719871185810 EUDAMED04719871185124 EUDAMED04719871185711 EUDAMED04719871185766 EUDAMED04719871185728 EUDAMED04719871183335 EUDAMED04719871185650 EUDAMED04719871185681 EUDAMED04719871185704 EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMEDZ12130202 TRACTION SYSTEMS EUDAMEDZ12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Everyway by Everyway Medical Instrument Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 471987118-ELECTRODE-H5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Everyway Medical Instrument Co., Ltd.
- EUDAMED SRN
- TW-MF-000009887
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (17)
- EUDAMED ba6c023f-9fc1-4209-9934-6c0e16a12b33 61 fields · synced Aug 4, 2026
- EUDAMED 384baae5-616d-4260-968a-6a3feec9f36f 61 fields · synced May 16, 2026
- EUDAMED b33c3b56-5fa1-4cde-9190-1a1eadc33987 61 fields · synced May 16, 2026
- EUDAMED 85a12d98-f741-421f-9cb6-c87b8c618ca9 61 fields · synced May 16, 2026
- EUDAMED 0dc3cb5c-4fb3-449b-9535-eaca4dd8089f 61 fields · synced May 17, 2026
- EUDAMED 3a66300e-1999-4236-b92f-d7f4af5d7362 61 fields · synced May 17, 2026
- EUDAMED 54044e08-c79e-4697-a29d-639a33d3dc12 61 fields · synced May 17, 2026
- EUDAMED aee71867-8085-4df3-b5db-146a833ca7ce 61 fields · synced May 18, 2026
- EUDAMED 153cffa2-b543-4721-b57a-292fb63110b0 61 fields · synced May 18, 2026
- EUDAMED 56766ba9-7e16-4aec-b95a-158a58454954 61 fields · synced May 18, 2026
- EUDAMED a5e35e53-7247-4a4d-a8eb-709d10ce0209 61 fields · synced May 18, 2026
- EUDAMED 9e2573cc-481c-423c-aed5-480854d99184 61 fields · synced May 18, 2026
- FDA UDI cebd2e6e-2176-4a84-9234-bd70f1f3764b 33 fields · synced May 30, 2026
- EUDAMED 148f0179-53d6-4a9c-8126-b49de09ff583 61 fields · synced Jul 9, 2026
- EUDAMED c3444a92-bfa3-4226-b757-37ef6b4a50cf 61 fields · synced Jul 10, 2026
- EUDAMED ec357256-51ab-44b8-b83c-f90f6f6f02e3 61 fields · synced Jul 19, 2026
- EUDAMED a3cbb5dc-891f-4b5a-9f80-55a5a45d4a2b 61 fields · synced Jul 22, 2026