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1PLY Coolmax Sock Wide Regular w/Plastic
EUDAMEDFDA UDIClass I (EU MDR)
Ref KCW 14-1HR
Identity
- Trade Name
- 1PLY Coolmax Sock Wide Regular w/Plastic EUDAMEDCOOLMAX SOCK FDA UDI
- Generic Name
- Stump sock FDA UDI
- Device Name
- COOLMAX SOCK EUDAMED1PLY Coolmax Sock Wide Regular w/Plastic FDA UDI
- Model / Reference
- KCW 14-1HR EUDAMEDFDA UDI
- Description
- 1PLY Coolmax Sock Wide Regular w/Plastic FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980007029 EUDAMEDFDA UDI
- Basic UDI-DI
- 07139801000300279 EUDAMED
- FDA Product Code
- IPM FDA UDI
- EMDN Code
- Y090327 SOCKS FOR PROSTHESES EUDAMED
- GMDN Term
- Stump sock FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
1PLY Coolmax Sock Wide Regular w/Plastic by Alps South, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 | 07139801000300279 | 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 08a14f47-6f8e-4301-83e6-18d65e920696 61 fields · synced Jun 19, 2026
- FDA UDI f746af16-002a-4996-a5fe-c285740001a1 33 fields · synced May 29, 2026