Identity
- Trade Name
- URGOTUL ABSORB BORDER FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- An adhesive lipido-colloid foam dressing with soft-adherent TLC and silicone border. Composed of : - a soft-adherent TLC layer combined with an absorbent polyurethane foam pad and a superabsorbent layer - a vapour permeable waterproof outer film with silicone adhesive on the edges FDA UDI
- Model / Reference
- 550765 FDA UDI
- Description
- An adhesive lipido-colloid foam dressing with soft-adherent TLC and silicone border. Composed of : - a soft-adherent TLC layer combined with an absorbent polyurethane foam pad and a superabsorbent layer - a vapour permeable waterproof outer film with silicone adhesive on the edges FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03546890035113 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
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Urgotul Absorb Border by Laboratoires Urgo — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.
- Suprasorb — Huizhou Foryou Medical Devices Co., Ltd. · Class I
- Proximel Silicone Dressing 5x5 — HARTMANN USA INC. · Class I
- Healqu — HEALQU LLC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Curity — Cardinalhealth · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laboratoires Urgo
Sources (2)
- FDA UDI 3c0ab9df-b5bc-4606-a3fb-6b6e8dda01f2 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026