Armboard US with Clamshell Armboard Pad 3"/7, 5cm BLK (ea)
Ref KTEK2000-2052Model Kyra, KTEK Armboards and holders
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08500202851002001PT 00810121680155 | Date20 Jul 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- Withdrawn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
- Device Name
- Arm Positioners
- Model / Reference
- Kyra, KTEK Armboards and holders, KTEK2000-2052
- Primary DI / UDI-DI
- 00810121680155
- Basic UDI-DI
- 08500202851002001PT
- Direct Marketing DI
- 00810121680155
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000003935
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
From the manufacturer
Manufacturer's product page: Armboards & Pads
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