Identity
- Trade Name
- Silhouette Soft EUDAMED
- Device Name
- Silhouette Soft EUDAMED
- Model / Reference
- SMS 26 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060033042816 EUDAMED
- Basic UDI-DI
- B-05060033042816 EUDAMED
- EMDN Code
- H0101010199 MONOFILAMENT ABSORBABLE SYNTHETIC SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Silhouette Soft by Sinclair Pharma US Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05060033042816 | Class III | Active |
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Manufacturer
- Manufacturer
- Sinclair Pharma US Inc.
- EUDAMED SRN
- US-MF-000035849
- Authorised Representative
- Sinclair France SAS FR-AR-000008944
Sources (1)
- EUDAMED 59e7df17-51bf-4876-8e40-fb1cb67c2c38 61 fields · synced Jun 18, 2026