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RejuvaSil Silicone Scar Gel 10 ml
EUDAMEDFDA UDIClass I (EU MDR)
Ref 80010Model 88888
by Scar Heal
Identity
- Trade Name
- RejuvaSil Silicone Scar Gel 10 ml EUDAMEDRejuvaSil FDA UDI
- Generic Name
- Scar-management dressing, single-use FDA UDI
- Device Name
- RejuvaSil Silicone Scar Gel EUDAMEDRejuvaSil Silicone Scar Gel 10 ml FDA UDI
- Model / Reference
- 88888 EUDAMED80010 EUDAMEDFDA UDI
- Description
- RejuvaSil Silicone Scar Gel 10 ml FDA UDI
Identifiers
- Catalog Number
- 80010 FDA UDI
- Primary DI / UDI-DI
- 00642790800103 EUDAMEDFDA 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 — 10 Milliliter FDA UDI
RejuvaSil Silicone Scar Gel 10 ml by Scar Heal — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 64279088888W2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- EUDAMED b9c89181-9ba8-4e40-8ed7-a85884cc5bac 61 fields · synced Jul 19, 2026
- FDA UDI 394a806c-c6c1-4b80-b57c-0b774ae8f8fb 37 fields · synced May 29, 2026