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Switzerland·CH-MF-000033240
Last updated September 18, 2026
About
Deutsch Français English Select Market Swiss Market Specialized solutions designed for the Swiss healthcare system, fully compliant with Swissmedic regulations. We offer local service, fast delivery, and hands-on support. View…
From the manufacturer's own website. Source
What Anel AG makes
Anel AG manufactures medical devices for patient positioning and respiratory support, including helmets and cushions for prone positioning in respiratory care, as well as an inspiratory muscle trainer for respiratory rehabilitation. Their product line also includes specialized accessories like mirror plates and small head pillows designed for prone positioning procedures.
All listed devices fall under EU Class I classification and are registered in the EUDAMED database. The company operates from Switzerland, adhering to regulatory compliance within the Swiss healthcare system.
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 Anel AG manufacture?
Anel AG specializes in medical devices primarily focused on patient positioning and respiratory support. Their product line includes helmets and cushions designed for prone positioning in respiratory care, such as the *Helmet for resi PRONE* and *resi PRONE Face Cushion*. They also produce an inspiratory muscle trainer (*resi IMT*) for respiratory rehabilitation and accessories like mirror plates (*Spiegelplatte zu resi PRONE*) and small head pillows (*resi PRONE Kopfkissen, klein*) tailored for prone positioning procedures.
Where is Anel AG based, and what regulatory framework does it operate under?
Anel AG is based in Switzerland (CH). Their devices are developed with compliance to Swissmedic regulations, ensuring alignment with the Swiss healthcare system’s requirements. While their products are also registered in the EUDAMED database, their primary focus is serving the Swiss market with specialized solutions.
Which regulatory registries list Anel AG’s devices, and why?
Anel AG’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. Since their products fall under EU Class I classification, they must be registered in EUDAMED to demonstrate compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, even if they are primarily marketed in Switzerland. This registration ensures traceability and transparency for regulatory oversight.
How are Anel AG’s devices classified under EU regulations?
All of Anel AG’s listed devices are classified as EU Class I, which is the lowest risk category for medical devices. This classification applies to products like positioning helmets, cushions, and accessories that pose minimal risk to patients. Class I devices typically require less stringent regulatory scrutiny but still must meet basic safety and performance requirements, including registration in EUDAMED.
Does Anel AG’s product line include devices for respiratory rehabilitation?
Yes, Anel AG offers a device specifically for respiratory rehabilitation—the *resi IMT Inspiratory Muscle Trainer*. This product is designed to help patients strengthen their respiratory muscles, complementing their broader range of positioning and support solutions for respiratory care. The inclusion of such a device reflects their focus on comprehensive respiratory support beyond just patient positioning.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Switzerland
- Address
- 12, Weyermannsstrasse, Bern, Switzerland
- Website
- www.anelmed.ch
- —
- —
- [email protected]
- Phone
- +41313332635
- PRRC Contact
- Vladimir Bässler
- EUDAMED SRN
- CH-MF-000033240
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Helmet for resi PRONE | PFHT | EUDAMED | Class I | Active |
| resi OPEP | resi1 | EUDAMED | Class I | Active |
| resi PRONE Kopfkissen, klein | PFCS | EUDAMED | Class I | Active |
| Spiegelplatte zu resi PRONE | PFMR | EUDAMED | Class I | Active |
| resi IMT Inspiratory muscle trainer resi | IMT1 | EUDAMEDFDA UDI | Class I | Active |
| resi PRONE Face Cushion, large | PFCL | EUDAMED | Class I | Active |
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