Bohemia Ergonomic
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Bohemia Ergonomic device is a cutting-edge medical product designed to provide accurate and reliable measurements of human tissue, particularly in the context of implantable devices. Developed in compliance with international standards, this device is used to ensure precise sizing and placement of implants, minimizing the risk of complications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08595193700216V5 | Date18 Mar 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Bohemia ErgonomicBohemia Ergonomic Neo
- Device Name
- Matrace Bohemia pro vysoké riziko vzniku dekubitů
- Primary DI / UDI-DI
- 08595193700339, 08595193700322
- Basic UDI-DI
- 08595193700216V5
- EMDN Code
- V080702 Non active anti-decubitus medical mattresses
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000051784
Other devices from LB BOHEMIA, s.r.o.
Properties
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