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Coolmax Sock Wide Long w/Hole Bundle of 12
EUDAMEDFDA UDIClass I (EU MDR)
Ref KCW 18-H-BUNDLE
Identity
- Trade Name
- Coolmax Sock Wide Long w/Hole Bundle of 12 EUDAMEDCOOLMAX SOCK FDA UDI
- Generic Name
- Stump sock FDA UDI
- Device Name
- COOLMAX SOCK EUDAMEDCoolmax Sock Wide Long w/Hole Bundle of 12 FDA UDI
- Model / Reference
- KCW 18-H-BUNDLE EUDAMEDFDA UDI
- Description
- Coolmax Sock Wide Long w/Hole Bundle of 12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980013150 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
Coolmax Sock Wide Long w/Hole Bundle of 12 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 06d12f48-33b1-411a-9b1d-9c64767547eb 61 fields · synced Jun 18, 2026
- FDA UDI 33b164b1-4fd3-4845-b20a-c28740cf5fe7 33 fields · synced May 30, 2026