Iceross® Sport Locking
by Össur Iceland ehf. 29 variants
Ref I-103328Model BU00003
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Introducing the Iceross Sport Locking device, a high-quality medical device designed for temporary and implantable use in various surgical procedures. With its advanced sterile technology and Class I classification, this device is ideal for patients requiring temporary locking solutions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00003MX 05690967118990 | Date26 May 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- Withdrawn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
- Model / Reference
- BU00003, I-103328
- Primary DI / UDI-DI
- 05690967118990
- Basic UDI-DI
- 5690967BU00003MX
- EMDN Code
- Y062409 Transtibial prostheses (for amputation under knee)
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IS-MF-000000173
Other devices from Össur Iceland ehf.
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