KTEK Armboard, JP
by Kyra Medical, Inc. EUDAMED
Active
Ref KTEK2008Model Kyra, KTEK Armboards and holders
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08500202851002001PT | Date20 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Arm Positioners
- Model / Reference
- Kyra, KTEK Armboards and holders, KTEK2008
- Primary DI / UDI-DI
- 00856514007925
- Basic UDI-DI
- 08500202851002001PT
- Direct Marketing DI
- 00856514007925
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000003935
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Kyra Medical, Inc.
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