Identity
- Trade Name
- Guardian EUDAMEDFDA UDI
- Generic Name
- Mechanical-resistance external knee prosthesis FDA UDI
- Device Name
- External Prosthetic Knee EUDAMEDGuardian Friction Knee Assembly FDA UDI
- Model / Reference
- GFKA 120 EUDAMEDFDA UDI
- Description
- Guardian Friction Knee Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841747178412 EUDAMEDFDA UDI
- Basic UDI-DI
- 08417471MYKNEE19883V EUDAMED
- FDA Product Code
- ISY FDA UDI
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) EUDAMED
- GMDN Term
- Mechanical-resistance external knee prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechatronic external knee prosthesis
Guardian by College Park Industries, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08417471MYKNEE19883V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- College Park Industries, Inc.
- EUDAMED SRN
- US-MF-000002352
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7231eb49-e15b-4315-bddf-695b29d50bd7 61 fields · synced Jun 18, 2026
- FDA UDI 2a101c6d-8878-4c42-998b-33d39bab9543 33 fields · synced May 30, 2026