Identity
- Trade Name
- ENLIGHT 1810 FDA UDI
- Generic Name
- Thoracic electrical impedance system, tomographic FDA UDI
- Device Name
- "ENLIGHT 1810 is a non-invasive and non-radiation medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as adjunctive tool to be used with other clinical information to assess the patient’s ventilation. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm. ENLIGHT1810 and its accessories are prescription use only." FDA UDI
- Model / Reference
- TP-ENU00-0 FDA UDI
- Description
- "ENLIGHT 1810 is a non-invasive and non-radiation medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as adjunctive tool to be used with other clinical information to assess the patient’s ventilation. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm. ENLIGHT1810 and its accessories are prescription use only." FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898959841415 FDA UDI
- 510(k) Number
- DEN170072 FDA UDI
- FDA Product Code
- QEB FDA UDI
- GMDN Term
- Thoracic electrical impedance system, tomographic 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
No
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
MR Unsafe FDA UDI
Category: Thoracic electrical impedance system, tomographic
Enlight 1810 by Timpel S/A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN170072 also covers:
- 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
- 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 a47245bc-0069-4c43-91d1-0d216945adc4 36 fields · synced May 30, 2026