Identity
- Trade Name
- ScarSil EUDAMEDFDA UDI
- Generic Name
- Scar-management dressing, single-use FDA UDI
- Device Name
- RejuvaSil Silicone Scar Gel EUDAMEDScarSil Silicone Scar Gel 30 ml FDA UDI
- Model / Reference
- 88888 EUDAMED85010 EUDAMED85000 FDA UDI
- Description
- ScarSil Silicone Scar Gel 30 ml FDA UDI
Identifiers
- Catalog Number
- 85000 FDA UDI
- Primary DI / UDI-DI
- 00642790850108 EUDAMED00642790850009 FDA UDI
- Basic UDI-DI
- 64279088888W2 EUDAMED
- FDA Product Code
- MDA FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Scar-management dressing, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 30 Milliliter FDA UDI
Category: Scar-management dressing, single-use
ScarSil by Scar Heal — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Scar-management dressing, single-use.
- ScarAway Silicone Acne Scar Gel — ALLIANCE PHARMA INC. · Class I
- H&H — TRONJEN MEDICAL TECHNOLOGY INC. · Class I
- Kelo-cote Advanced Formula Scar Gel — ALLIANCE PHARMA INC. · Class I
- NewGel+UV Silicone Gel for Scars + SPF30 — Newmedical Technology, Inc. · Class I
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp. · Class I
- ScarMD — AIM MEDICAL INC · Class I
- ScarAway Silicone Scar Gel — ALLIANCE PHARMA INC. · Class I
- Lorski — Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office · 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 |
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Manufacturer
- Manufacturer
- Scar Heal
Sources (2)
- FDA UDI 2296e958-2578-43e9-b7f8-70685fced182 37 fields · synced Jul 11, 2026
- EUDAMED a8e0fc58-ef15-4278-abd9-b0b7924e57d4 61 fields · synced Jul 11, 2026