Identity
- Trade Name
- URGOTUL ABSORB FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- A soft-adherent lipido-colloid foam dressing with TLC. Composed of: - a soft-adherent TLC layer made up of polymers and hydrocolloid particles combined with an absorbent polyurethane foam pad - and a protective non-woven polyurethane backing. FDA UDI
- Model / Reference
- 603650 FDA UDI
- Description
- A soft-adherent lipido-colloid foam dressing with TLC. Composed of: - a soft-adherent TLC layer made up of polymers and hydrocolloid particles combined with an absorbent polyurethane foam pad - and a protective non-woven polyurethane backing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03546890045174 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Urgotul Absorb 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 a64f7aff-8988-4f0c-b4e0-53aceb58d16a 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026