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VersaTrode
EUDAMEDClass I (EU MDR)
Ref HTFS323Model VersaTrodeRef HTFS365Ref VELL-WETRef FW55Ref FW60Ref HTFW50RRef HTFS50Ref FW40DRef HTFW323RRef FS32PRRef HTFW365Ref HTFW323BRef HTFW365BRef FS50Ref FS32PRef HTFS323R
Identity
- Trade Name
- VersaTrode EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- VersaTrode EUDAMEDHTFS323 EUDAMEDHTFS365 EUDAMEDVELL-WET EUDAMEDFW55 EUDAMEDFW60 EUDAMEDHTFW50R EUDAMEDHTFS50 EUDAMEDFW40D EUDAMEDHTFW323R EUDAMEDFS32PR EUDAMEDHTFW365 EUDAMEDHTFW323B EUDAMEDHTFW365B EUDAMEDFS50 EUDAMEDFS32P EUDAMEDHTFS323R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060441918482 EUDAMED05060441918444 EUDAMED05060441918512 EUDAMED05060441914149 EUDAMED05060441918420 EUDAMED05060441917416 EUDAMED05060441917393 EUDAMED05060441914156 EUDAMED05060441917423 EUDAMED05060441914101 EUDAMED05060441918383 EUDAMED05060441918505 EUDAMED05060441918475 EUDAMED05060441918451 EUDAMED05060441914125 EUDAMED05060441918499 EUDAMED
- Basic UDI-DI
- 506044191ECG-Elec2R3 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electrocardiographic electrode, single-use
VersaTrode by Nissha Medical Technologies Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506044191ECG-Elec2R3 | Class I | Active |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Ltd
- EUDAMED SRN
- GB-MF-000012057
- Authorised Representative
- NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795
Sources (16)
- EUDAMED ebb5b9d4-ee3d-4902-801c-26d670d27352 61 fields · synced Jul 31, 2026
- EUDAMED 3f96176d-46f6-41f9-82c4-6a08f71c2d98 61 fields · synced May 17, 2026
- EUDAMED f589e78f-89fb-4842-a6fa-d7e7c65a1c1b 61 fields · synced May 17, 2026
- EUDAMED ce922faf-20d0-43a8-81a8-1a3cd81e1529 61 fields · synced May 17, 2026
- EUDAMED e420719f-8bc5-40c3-aba8-4f6acef7eba1 61 fields · synced May 17, 2026
- EUDAMED 02c9e0c9-c9ec-4a27-9d7e-0f469187aab3 61 fields · synced May 17, 2026
- EUDAMED 3708bb38-3051-4de7-a7ce-67eedd6b37ef 61 fields · synced May 17, 2026
- EUDAMED 38141b09-752c-4b8f-a316-1b45ea220bca 61 fields · synced May 18, 2026
- EUDAMED 92fbc726-7d73-4920-b924-f7d853f8161d 61 fields · synced May 18, 2026
- EUDAMED 33635322-4255-4c06-8695-6092b83af248 61 fields · synced May 18, 2026
- EUDAMED 1c463ae9-f859-4e49-b884-a375792a4b27 61 fields · synced May 18, 2026
- EUDAMED 0784c597-4bf4-4461-a0a9-b1798a995340 61 fields · synced May 18, 2026
- EUDAMED 54d3db80-93a9-4778-a3a9-c9b61993e0c3 61 fields · synced May 18, 2026
- EUDAMED efc95b41-ea60-445e-ab7b-4acddf392fc5 61 fields · synced May 19, 2026
- EUDAMED 7b987c95-671f-492e-8497-4235e6089360 61 fields · synced May 19, 2026
- EUDAMED 503471cb-524b-451d-9e63-38129c39fd59 61 fields · synced May 19, 2026