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Scar Fx Silicone Sheeting Breast Piece
EUDAMEDFDA UDIClass I (EU MDR)
Ref 11234Model 11111
by Scar Heal
Identity
- Trade Name
- Scar Fx Silicone Sheeting Breast Piece EUDAMEDScar Fx FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Scar Fx Silicone Sheeting EUDAMEDScar Fx Silicone Sheeting Breast Piece FDA UDI
- Model / Reference
- 11111 EUDAMED11234 EUDAMEDFDA UDI
- Description
- Scar Fx Silicone Sheeting Breast Piece FDA UDI
Identifiers
- Catalog Number
- 11234 FDA UDI
- Primary DI / UDI-DI
- 00642790112343 EUDAMEDFDA UDI
- Basic UDI-DI
- 64279011111PW EUDAMED
- FDA Product Code
- MDA FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Scar-management dressing, reusable 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
No
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
Scar Fx Silicone Sheeting Breast Piece 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 | 64279011111PW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- EUDAMED 2276200d-c37e-4443-97a4-75b7860ece69 61 fields · synced Jun 19, 2026
- FDA UDI b149bb61-4ad8-4c13-ba4d-099dbc6f580d 36 fields · synced May 29, 2026