High flow 100 Heavy Duty
by Van der Mark Anti Decubitus Systemen Netherlands EUDAMED
Ref 20208105Model Luchtwisseldruk matras EMDN V080701
Overview
High Flow 100 Heavy Duty medical device is a high flow isolation mattress designed to provide optimal comfort and support for patients in intensive care units (ICUs) or other areas of high-acuity care where decubitus ulcers are a significant concern. This device features a durable, easy-to-clean design, a breathable mesh surface, and a range of sensors that track vital signs and monitor the patient's position and movement.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8720256271AD11208RW | Date22 Jun 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Luchtwisseldruk matras
- Model / Reference
- Luchtwisseldruk matras, 20208105
- Primary DI / UDI-DI
- 08720256271031
- Basic UDI-DI
- 8720256271AD11208RW
- Direct Marketing DI
- 08720256271031
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000005763
Other devices from Van der Mark Anti Decubitus Systemen
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 2905047a-82f5-4e0d-ac50-4d3e23d76bae