Identity
- Trade Name
- URGOK2 LITE FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- A 2-layer reduced multicomponent compression bandage system, composed of a short stretch bandage and a long stretch bandage. Layer 1, KTECH Lite/KTECH Reduced composition: wadding: viscose, polyester; knitted layer: polyamide, elastane. Layer 2, KPRESS composition: cotton, polyester, polyamide, elastane; synthetic latex free cohesive material. FDA UDI
- Model / Reference
- 553246 FDA UDI
- Description
- A 2-layer reduced multicomponent compression bandage system, composed of a short stretch bandage and a long stretch bandage. Layer 1, KTECH Lite/KTECH Reduced composition: wadding: viscose, polyester; knitted layer: polyamide, elastane. Layer 2, KPRESS composition: cotton, polyester, polyamide, elastane; synthetic latex free cohesive material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03546890028450 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Compression bandaging kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compression bandaging kit
Urgok2 Lite by Laboratoires Urgo — 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
- Laboratoires Urgo
Sources (2)
- FDA UDI 327ee719-3413-4c55-abc6-fb959e86998b 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026