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
2021-05-10
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
2019-10-28
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 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 - 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 - 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 - 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 - 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 - XL - 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. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
ENLIGHT BELT - 5S - 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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
ENLIGHT BELT - XL - 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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
ENLIGHT BELT - XXS - 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. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
ENLIGHT BELT - XXS - 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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
ENLIGHT BELT - 5S - 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. Non-sterile and not to be sterilized. It must be used with Addere.
2023-09-01
ENLIGHT 2100 - ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient’s thorax.This information is presented to the clinician user as an 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 patients in a hospital setting, whose thorax perimeter is within the range of 78 -122 cm.
2021-04-20
ENLIGHT ELECTRODE ADDERE- SIZE 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.
2022-03-30
ENLIGHT ELECTRODE ADDERE- SIZE 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.
2022-03-30
ENLIGHT ELECTRODE ADDERE- SIZE 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.
2022-03-30
ENLIGHT ELECTRODE ADDERE- SIZE 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.
2022-03-30