Topivac
by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 6 variants
Part of a family of 10 devices: see the family page
Ref HAND T-NPWT DeviceModel Hand Handy T-NPWT Device
Topivac (HAND T-NPWT Device) is a Class IIa device made by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 868316111TOPIVACDEVST), active as of 7 Nov 2026.
Active
CE MDR 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 | Number868316111TOPIVACDEVST 08683161110034 | Date2 Nov 2026 | StatusActive |
| European Union | CE/MDR | Number868316111TOPIVACDEVST 08683161110034 | Date2 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 868316111TOPIVACDEVST
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device name
- Topivac Handy Wound Care Therapy DeviceDigital Hand Vacuum Assisted (NPWT) Wound Closure Therapy Device
- Model / reference
- Hand Handy T-NPWT Device, HAND T-NPWT Device
- Primary DI / UDI-DI
- 08683161110034
- Basic UDI-DI
- 868316111TOPIVACDEVST, B-08683161110034
- Direct marketing DI
- 08683161110034
- EMDN code
- Z12019003 Wound treatment equipment
- Device class
- Class IIa
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- TR-MF-000016889
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