Identity
- Trade Name
- Rystora® Silicone Scar Sheets(Non-sterile) EUDAMEDRystora® Scar Sheets FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Rystora® Silicone Scar Sheets(Non-sterile) EUDAMED
- Model / Reference
- SA042512 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 14711182607002 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14711182607002 EUDAMED
- FDA Product Code
- MDA FDA UDI
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER 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
- Italy 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, reusable
Rystora® Scar Sheets by Fortune Medical Instrument Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (2)
- FDA UDI fa4a1de0-db43-4f81-9010-961d335e220b 32 fields · synced Jun 18, 2026
- EUDAMED 8a4109a0-4f72-4a6d-ab86-bc5f0558561d 61 fields · synced Jun 18, 2026