Identity
- Trade Name
- URGOK2 FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- A 2-layer multicomponent compression system composed of a short stretch bandage and a long stretch bandage. Layer 1, KTECH 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
- 553244 FDA UDI
- Description
- A 2-layer multicomponent compression system composed of a short stretch bandage and a long stretch bandage. Layer 1, KTECH 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
- 03546890028474 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 by Laboratoires Urgo — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Compression bandaging kit.
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laboratoires Urgo
Sources (1)
- FDA UDI f8a4443b-39fb-4293-8b50-f55a470cbdf0 35 fields · synced Jun 8, 2026