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Butterfly Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref E-BF155Model Adhesive Electrodes
by TensCare Ltd
Identity
- Trade Name
- Butterfly Electrodes EUDAMEDTensCare FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Electrode, transcutaneous, electric nerve EUDAMEDThe Butterfly Electrode pads, is a pack of 2 reusable electrodes, with an intended use for the desired success of any stimulation (TENS or EMS). They are intended for a single user. FDA UDI
- Model / Reference
- Adhesive Electrodes EUDAMEDE-BF155 EUDAMEDButterfly Electrode pads FDA UDI
- Description
- The Butterfly Electrode pads, is a pack of 2 reusable electrodes, with an intended use for the desired success of any stimulation (TENS or EMS). They are intended for a single user. FDA UDI
Identifiers
- Catalog Number
- E00032 FDA UDI
- Primary DI / UDI-DI
- 05033435134199 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435E00013WR EUDAMED
- 510(k) Number
- K210448 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Poland 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Butterfly Electrodes by TensCare 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 | 5033435E00013WR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 167855e2-4184-41ae-b7f8-7e75d0b8a75c 61 fields · synced Jul 14, 2026
- FDA UDI 06b10f99-e3b8-48ee-9c80-dc1770a648b4 35 fields · synced May 30, 2026