Identity
- Trade Name
- LEADWIRE KIT FOR MEDIBYTE EUDAMEDBRAEBON Leadwire Kit for MediByte FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- LEADWIRES EUDAMEDLeads for connecting electrodes to a MediByte. FDA UDI
- Model / Reference
- 8620 EUDAMEDFDA UDI
- Description
- Leads for connecting electrodes to a MediByte. FDA UDI
Identifiers
- Catalog Number
- 8620 FDA UDI
- Primary DI / UDI-DI
- B14086201 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140Leadwire8Z EUDAMED
- Unit of Use DI
- B14086200 EUDAMED
- 510(k) Number
- K061764 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 24 Inch FDA UDILength — 60 Inch FDA UDI
The Leadwire Kit for Medibyte is a medical device used in the treatment of endocrine disorders. It features a proprietary leadwire technology, ensuring precise and safe implantation.
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 | ++B140Leadwire8Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED ba89750c-3137-4919-ab40-ee3c7350334d 61 fields · synced Jul 12, 2026
- FDA UDI ed40f5af-8431-4094-9967-00ab87fe0a86 38 fields · synced May 30, 2026