Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
- Device Name
- K3 Foot with Pyramid EUDAMEDTRULIFE ZENITH FOOT 24CM LEFT CAT 3 DK BRN FDA UDI
- Model / Reference
- SZM450-25-L EUDAMEDSZN203-24-L-3 FDA UDI
- Description
- TRULIFE ZENITH FOOT 24CM LEFT CAT 3 DK BRN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517872186 EUDAMEDFDA UDI
- Basic UDI-DI
- 00645517FootK3YT EUDAMED
- FDA Product Code
- ISH FDA UDI
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
- GMDN Term
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical-resistance external ankle-foot prosthesis
Trulife by Trulife Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trulife Limited
Sources (2)
- FDA UDI 14df039b-f00b-4225-97ae-b77606c3f1f0 33 fields · synced Jul 12, 2026
- EUDAMED 9b566828-8fb9-49d2-8faf-65fa85b2a36a 61 fields · synced Jul 12, 2026