timpelmedical.comEnlight 2100
Timpel S.A.
TIMPEL S.A.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016509761 | 3016509761 | TIMPEL S.A. | 1 | N | 2026-01-01 | Rua Jose Leonardi 280 Bloco A Pato Branco Parana BR 85503 |
| 3017008373 | 3017008373 | TIMPEL MEDICAL CORP | 1 | Y | 2026-01-01 | 300 Delaware Avenue Suite 256 Wilmington DE US 19801 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07898959841170 | ENLIGHT ELECTRODE ADDERE- SIZE XS - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized. | +551130880305 | qualidade@timpelmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 237237 | 2071540320 | K250464 | Enlight 2100 (TPL-E2103-0) | QEB | 2025-09-10 |
| 237237 | 1800334795 | K222897 | Enlight 2100 | QEB | 2023-03-07 |
| 237237 | 2063710776 | K211135 | Enlight 2100 | QEB | 2022-01-06 |
| 237237 | 1711863893 | DEN170072 | Enlight 1810 | QEB | 2018-12-20 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QEB | 4 | 2025-09-10 |
PMN#
Enlight 2100
Timpel S.A.
GUDID#
SHAPER No.2 - The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized
2019-10-28
SHAPER No.1 - The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized.
2019-10-28
SHAPER No.2 - The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized
2021-05-10
ENLIGHT ELECTRODE ADDERE- SIZE L - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2019-10-28
ENLIGHT ELECTRODE ADDERE- SIZE M - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2019-10-28
ENLIGHT ELECTRODE ADDERE- SIZE S - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2019-10-28
ENLIGHT ELECTRODE ADDERE- SIZE XS - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2019-10-28
ENLIGHT ADDERE - 5S - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - 4S - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - P2 - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - P1 - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - P0 - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - XL - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - XXS - Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - 5S - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - 4S - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - P2 - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - P1 - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - P0 - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - XL - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT ADDERE - XXS - Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
2024-05-13
ENLIGHT BELT - L – LEFT - 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.
2019-10-28
ENLIGHT BELT - L – RIGHT - 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.
2019-10-28
ENLIGHT BELT - M – LEFT - 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.
2019-10-28
ENLIGHT BELT - M – RIGHT - 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.
2019-10-28
ENLIGHT BELT - S - LEFT - 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.
2019-10-28
ENLIGHT BELT - S - RIGHT - 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.
2019-10-28
ENLIGHT BELT - XS – LEFT - 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.
2019-10-28
ENLIGHT BELT – XS – RIGHT - 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.
2019-10-28
ENLIGHT 1810 - """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."""
2019-10-28
ENLIGHT BELT - M – LEFT - 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.
2021-05-10
ENLIGHT BELT - L – LEFT - 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.
2021-05-10
ENLIGHT BELT - L – RIGHT - 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.
2021-05-10
ENLIGHT BELT - M – RIGHT - 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.
2021-05-10
ENLIGHT BELT - S – LEFT - 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.
2021-05-10
ENLIGHT BELT - S - RIGHT - 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.
2021-05-10
ENLIGHT BELT - XS – LEFT - 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.
2021-05-10
ENLIGHT BELT – XS – RIGHT - 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.
2021-05-10
ENLIGHT 2100 - 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.
2022-03-30
ENLIGHT BELT – P2 – LEFT - 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 and pediatric patients, designed for exclusive use with ENLIGHT. Disposable. Non-sterile and not to be sterilized. It must be used with Addere.
2022-03-30