Identity
- Trade Name
- ENLIGHT BELT – XS – RIGHT FDA UDI
- Generic Name
- Thoracic electrical impedance electrode array, single-use FDA UDI
- Device Name
- The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult pediatric and neonatal patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. FDA UDI
- Model / Reference
- AD-04015 FDA UDI
- Description
- The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult pediatric and neonatal patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898959841644 FDA UDI
- 510(k) Number
- DEN170072 FDA UDI
- FDA Product Code
- QEB FDA UDI
- GMDN Term
- Thoracic electrical impedance electrode array, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1505 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thoracic electrical impedance electrode array, single-use
Enlight Belt – Xs – Right by Timpel S/A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic electrical impedance electrode array, single-use.
- ENLIGHT BELT - M – RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - L – LEFT — Timpel S/A · Class II
- ENLIGHT BELT – P2 – LEFT — Timpel S/A · Class II
- ENLIGHT BELT - XXS – LEFT — Timpel S/A · Class II
- ENLIGHT BELT - L – LEFT — Timpel S/A · Class II
- ENLIGHT BELT – 4S – LEFT — Timpel S/A · Class II
- ENLIGHT BELT – P2 – RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - S - RIGHT — Timpel S/A · Class II
Cleared under the same submission
DEN170072 also covers:
- ENLIGHT 1810 — Timpel S/A
- ENLIGHT 2100 — Timpel S/A
- ENLIGHT BELT - L – LEFT — Timpel S/A
- ENLIGHT BELT - L – LEFT — Timpel S/A
- ENLIGHT BELT - L – RIGHT — Timpel S/A
- ENLIGHT BELT - L – RIGHT — Timpel S/A
- ENLIGHT BELT - M – LEFT — Timpel S/A
- ENLIGHT BELT - M – LEFT — Timpel S/A
- ENLIGHT BELT - M – RIGHT — Timpel S/A
- ENLIGHT BELT - M – RIGHT — Timpel S/A
- ENLIGHT BELT - S - LEFT — Timpel S/A
- ENLIGHT BELT - S - RIGHT — Timpel S/A
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Timpel S/A
Sources (1)
- FDA UDI e053b01f-fc26-4040-a304-0c3148396acb 36 fields · synced Jun 8, 2026