Silk Suture
by Metaloplast podjetje za proizvodno, trgovsko in storitveno dejavnost d.o.o. Kobarid 55 variants
Ref S3921T
Silk Suture (S3921T) is a Class IIb device made by Metaloplast podjetje za proizvodno, trgovsko in storitveno dejavnost d.o.o. Kobarid, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-03830040013565), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-03830040013565 03830040013565 | Date30 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-03830040013565
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- S3921T
- Primary DI / UDI-DI
- 03830040013565
- Basic UDI-DI
- B-03830040013565
- EMDN code
- H010202020301 Silk with needle
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000004241
Similar devices in this category
Other devices filed under SILK WITH NEEDLE.
- DemeSILK SK163020F17P by DemeTECH Corp
- PERMA-HAND C014D by Ethicon Inc.
- Silk 6287 by Assut Medical Sàrl
- DemeSILK SK264018F4P by DemeTECH Corp
- TRUSILK 5F75DZF26-12 by HEALTHIUM MEDTECH LIMITED
- Silk 6365 by Assut Medical Sàrl
- Silkus TI/C-BRO/01 by TI Medical Private Limited
- MANI SUTURES SILK - 4-0 SILK 25 by MANI, INC.
- MANI SUTURES SILK - 6-0 SILK 34 by MANI, INC.