Identity
- Trade Name
- 3PLY; SZ 5,6 LNGTH 16-20 EUDAMEDCOOLBLUE SOCK FDA UDI
- Generic Name
- Stump sock FDA UDI
- Device Name
- COOLBLUE SOCK EUDAMED3ply;SZ 5,6 Lngth 16-20 FDA UDI
- Model / Reference
- CB3XWRG2 EUDAMEDFDA UDI
- Description
- 3ply;SZ 5,6 Lngth 16-20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980012160 EUDAMEDFDA UDI
- Basic UDI-DI
- 07139801000300177 EUDAMED
- FDA Product Code
- IPM FDA UDI
- EMDN Code
- Y090327 SOCKS FOR PROSTHESES EUDAMED
- GMDN Term
- Stump sock FDA UDI
- Models / Variants
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
3ply +1 more model by Alps South, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models — regulatory data on deviCERTS
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 | 07139801000300177 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 8c1a7559-54d9-41e2-877a-1fe57cdbd6e6 61 fields · synced Jun 19, 2026
- FDA UDI bd04093a-7aca-44ea-97b0-da15a963614b 33 fields · synced May 30, 2026