Ib-Er
by Ib-Er Makina Anonim Sirketi 977 variants
Ref Short28-cat5
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The IB-ER prosthetic device from IB-ER Makina Anonim Sirketi is a high-quality, Class I-level instrument designed for precise and accurate measurements. With its advanced technology and user-friendly interface, it is ideal for various medical applications, including orthopedic surgery, traumatology, and vascular medicine.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8680757250001AC 08680757255667 | 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- Withdrawn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
- Device Name
- Carbon Foot and Foot Shell
- Model / Reference
- Short28-cat5
- Primary DI / UDI-DI
- 08680757255667
- Basic UDI-DI
- 8680757250001AC
- EMDN Code
- Y062409 Transtibial prostheses (for amputation under knee)
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000045117
Other devices from Ib-Er Makina Anonim Sirketi
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