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Sign in to claim this brandTimpel S/A
US
Last updated May 24, 2026
What Timpel S/A makes
Timpel S/A manufactures single-use and reusable thoracic electrical impedance electrode arrays, including adhesive-backed and conductive tape variants, as well as chest positioners for electrode placement. Their product line also includes tomographic electrical impedance systems and non-scalp cutaneous leads designed for analytical applications.
These devices are classified as Class II under regulatory frameworks, with submissions listed in the FDA’s 510(k) and UDI registries. The company operates within the United States, adhering to domestic medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Timpel S/A manufacture?
Timpel S/A specializes in thoracic electrical impedance devices. Their product line includes single-use and reusable electrode arrays for the chest, such as adhesive-backed arrays and conductive tape variants. They also produce chest positioners for precise electrode placement, tomographic electrical impedance systems, and non-scalp cutaneous leads for analytical monitoring. These devices are primarily used in medical settings where impedance-based measurements are critical.
Where is Timpel S/A based, and how does that affect their regulatory compliance?
Timpel S/A is based in the United States, meaning their devices must comply with FDA regulations. Since their products fall under Class II classification, they are subject to stricter oversight, including premarket notifications (510(k)) and unique device identification (UDI) requirements. The company’s submissions appear in the FDA’s 510(k) and UDI registries, ensuring traceability and adherence to domestic medical device laws.
Which regulatory registries list Timpel S/A’s devices, and why does this matter?
Timpel S/A’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) submission demonstrates that each device meets regulatory standards for safety and effectiveness before market entry, while the UDI system ensures accurate identification and tracking of devices throughout their lifecycle. These registries provide transparency for healthcare providers, regulators, and patients regarding the authorized status of their products.
How are Timpel S/A’s devices classified, and what does that classification imply?
Timpel S/A’s devices are classified as Class II under FDA regulations. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and performance. While not as high-risk as Class III devices, Class II products still undergo rigorous review—such as 510(k) submissions—to confirm they meet regulatory requirements before being authorized for use.
What distinguishes Timpel S/A’s electrode arrays from other similar medical devices?
Timpel S/A’s electrode arrays are designed specifically for thoracic electrical impedance applications, including single-use, reusable, and adhesive-backed variants. Their products cater to precise monitoring needs, such as tomographic imaging and chest positioners for consistent electrode placement. The inclusion of both reusable and disposable options, along with specialized leads like non-scalp cutaneous variants, allows for flexibility in clinical settings where different patient needs or procedural requirements apply.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- timpelmedical.com
- —
- —
- [email protected]
- Phone
- +551130880305
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 897939320
Catalogue (79)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Enlight Electrode Addere- Size P0 | ACE-00054 | FDA UDI | Class II | Active |
| Enlight Electrode Addere - Size Xs | ACE-00030 | FDA UDI | Class II | Active |
| Enlight Belt - M – Right | ACE-00026 | FDA UDI | Class II | Active |
| Enlight Belt - Xxs – Left | ACE-00037 | FDA UDI | Class II | Active |
| Enlight Belt - Xxs - Left | ACE-0001D-0 | FDA UDI | Class II | Active |
| Enlight Electrode Addere- Size 4s | ACE-00053 | FDA UDI | Class II | Active |
| Enlight Belt - S - Right | ACE-0001G-0 | FDA UDI | Class II | Active |
| Enlight Belt - L – Left | ACE-00029 | FDA UDI | Class II | Active |
| Enlight Belt - L – Left | AD-04022 | FDA UDI | Class II | Active |
| Enlight Belt - S - Left | ACE-0001H-0 | FDA UDI | Class II | Active |
| Enlight Belt – P1 – Left | ACE-00047 | FDA UDI | Class II | Active |
| Enlight Belt – 4s – Right | ACE-00042 | FDA UDI | Class II | Active |
| Enlight Electrode Addere- Size Xs | AD-03006 | FDA UDI | Class II | Active |
| Enlight Electrode Addere - Size L | ACE-00033 | FDA UDI | Class II | Active |
| Enlight Belt - M – Left | ACE-00027 | FDA UDI | Class II | Active |
| Enlight Belt - L - Left | ACE-0001N-0 | FDA UDI | Class II | Active |
| Enlight Addere - P0 | ACE-0000P-0 | FDA UDI | Class II | Active |
| Enlight Belt - Xl - Left | ACE-0001Q-0 | FDA UDI | Class II | Active |
| Enlight Belt - S – Left | ACE-00025 | FDA UDI | Class II | Active |
| Enlight Belt - L - Right | ACE-0001M-0 | FDA UDI | Class II | Active |
| Enlight Belt – Xs – Right | ACE-00022 | FDA UDI | Class II | Active |
| Enlight Electrode Addere - Size M | ACE-00032 | FDA UDI | Class II | Active |
| Enlight Electrode Addere- Size P1 | ACE-00055 | FDA UDI | Class II | Active |
| Enlight Belt – P2 – Right | ACE-00048 | FDA UDI | Class II | Active |
| Enlight Addere - Xl | AD-0300A-1 | FDA UDI | Class II | Active |
| Enlight Belt - Xs – Left | AD-04016 | FDA UDI | Class II | Active |
| Enlight 2100 | K222897 | FDA 510(k) | Class II | Active |
| Enlight 2100 (TPL-E2103-0) | K250464 | FDA 510(k) | Class II | Active |
| Enlight 2100 | K211135 | FDA 510(k) | Class II | Active |
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