Foot Shell, Gen 2 High, Size 22 Dark 4 R
Ref FTC-2H-122D4-RLModel FTC-2H
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 | Number406440900000000FTC-2HFV 04064409073764 | Date8 Sep 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- Withdrawn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
- Footshell Gen2 High
- Model / Reference
- FTC-2H, FTC-2H-122D4-RL
- Primary DI / UDI-DI
- 04064409073764
- Basic UDI-DI
- 406440900000000FTC-2HFV
- EMDN Code
- Y062409 Transtibial prostheses (for amputation under knee)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000019567
- Authorised representative
- Ottobock SE & Co. KGaA DE-AR-000016531
Other devices from Otto Bock HealthCare LP
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