Trulife SFC190-22-L-K12
by Trulife Inc.
Ref SFC190-22-L-K12
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number00645517FootK3YT 00645517820965 | Date7 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00645517820965 | Date31 Dec 2022 | StatusListed |
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- Withdrawn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
- United States
Specification
- Trade name
- Trulife
- Generic name
- Mechanical-resistance external ankle-foot prosthesis
- Device name
- K3 Foot with Pyramid
- Model / reference
- SFC190-22-L-K12
- Primary DI / UDI-DI
- 00645517820965
- Basic UDI-DI
- 00645517FootK3YT
- FDA product code
- ISH
- EMDN code
- Y062409 Transtibial prostheses (for amputation under knee)
- GMDN term
- Mechanical-resistance external ankle-foot prosthesis
- Device class
- Class I
- Regulation number
- 890.3420
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Other devices from Trulife Inc.
Properties
Other properties (20)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Prescription use: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Serial number: No
- Expiration date: No