KTEK Comfort 250 Stirrup, SecureLok (pair)
by Kyra Medical, Inc. EUDAMED
Active
Ref KTEK7810Model Comfort Stirrups, Classic Stirrups, Clean Stirrups
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08500202851001001PL | Date17 Jun 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- Withdrawn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
- Leg Positioners
- Model / Reference
- Comfort Stirrups, Classic Stirrups, Clean Stirrups, KTEK7810
- Primary DI / UDI-DI
- 00850020285082
- Basic UDI-DI
- 08500202851001001PL
- Direct Marketing DI
- 00850020285082
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000003935
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
From the manufacturer
Manufacturer's product page: KYRA® Comfort™ 350 Stirrup
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