Identity
- Trade Name
- ENLIGHT 2100 FDA UDI
- Generic Name
- Thoracic electrical impedance system, tomographic FDA UDI
- Device Name
- ENLIGHT 2100 is a non-invasive, radiation free 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 other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 -134 cm. FDA UDI
- Model / Reference
- TPL-E2103-1 FDA UDI
- Description
- ENLIGHT 2100 is a non-invasive, radiation free 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 other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 -134 cm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898966433573 FDA UDI
- 510(k) Number
- K211135 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 2100 by Timpel S/A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic electrical impedance system, tomographic.
- 1ST283-100 LuMon™ Belt Size 92 — Sentec, Inc. · Class II
- 1ST120-100 LuMon™ Connector 2.0 — Sentec, Inc. · Class II
- 1ST272-100 LuMon™ Belt Size 19 — Sentec, Inc. · Class II
- 1ST285-100 LuMon™ Belt Size 116 — Sentec, Inc. · Class II
- 1ST282-100 LuMon™ Belt Size 80 — Sentec, Inc. · Class II
- 1ST284-100 LuMon™ Belt Size 104 — Sentec, Inc. · Class II
- 1ST278-100 LuMon™ Belt Size 47 — Sentec, Inc. · Class II
- 1ST274-100 LuMon™ Belt Size 26 — Sentec, Inc. · Class II
Cleared under the same submission
K211135 also covers:
- ENLIGHT ADDERE - 4S — Timpel S/A
- ENLIGHT ADDERE - 5S — Timpel S/A
- ENLIGHT ADDERE - P0 — Timpel S/A
- ENLIGHT ADDERE - P1 — Timpel S/A
- ENLIGHT ADDERE - P2 — Timpel S/A
- ENLIGHT ADDERE - XL — Timpel S/A
- ENLIGHT ADDERE - XXS — Timpel S/A
- ENLIGHT BELT - 4S - LEFT — Timpel S/A
- ENLIGHT BELT - 4S - RIGHT — Timpel S/A
- ENLIGHT BELT - 5S - LEFT — Timpel S/A
- ENLIGHT BELT - 5S - RIGHT — Timpel S/A
- ENLIGHT BELT - L - LEFT — 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 bc1fc903-92c4-484a-bdb4-e9bf7d0d1969 34 fields · synced May 30, 2026