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Unisilk
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref DW2954Model UNISILK510(k) K042282
Identity
- Trade Name
- UNISILK EUDAMED
- Device Name
- Sterile Single Use Natural Non-Absorbable Surgical Suture with or without needle EUDAMED
- Model / Reference
- UNISILK EUDAMEDDW2954 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06285379080424 EUDAMED
- Basic UDI-DI
- B-06285379080424 EUDAMED
- EMDN Code
- H010202020301,H010202020302 EUDAMED
Classification
- Device Class
- Class III 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
Unisilk by United Medical Industries Co. Ltd — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042282 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06285379080424 | Class III | Active |
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Manufacturer
- Manufacturer
- United Medical Industries Co. Ltd
- EUDAMED SRN
- SA-MF-000004541
- FDA Applicant
- United Medical Industries Co. , Ltd.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dc645062-a1e2-47e2-be3d-44c0fb382ad1 85 fields · synced Jun 18, 2026
- FDA 510(k) K042282 1 fields · synced May 18, 2026