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Rystora® Silicone Scar Sheet (Non-Sterile)
EUDAMEDClass I (EU MDR)
Ref SA050712
Identity
- Trade Name
- Rystora® Silicone Scar Sheet (Non-Sterile) EUDAMED
- Device Name
- Rystora® Silicone Scar Sheet (Non-Sterile) EUDAMED
- Model / Reference
- SA050712 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182607012 EUDAMED
- Basic UDI-DI
- B-04711182607012 EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Scar-management dressing, reusable
Rystora® Silicone Scar Sheet (Non-Sterile) by Fortune Medical Instrument Corp. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182607012 | Class I | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED e52bc306-230c-4686-8831-5e091f7f8396 61 fields · synced Sep 17, 2026