Topivac
by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 19 variants
Ref ATPVSO3AMModel OZONE BAG
Topivac (ATPVSO3AM) is a medical device (EU MDD Class IIb; EMDN category wound treatment equipment) made by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 868316111OZONBAG27), 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 | Number868316111OZONBAG27 08683161110461 | Date4 Nov 2026 | StatusActive |
| European Union | CE/MDR | Number868316111OZONBAG27 08683161110461 | Date4 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 868316111OZONBAG27
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device name
- Ozonebag Medium Hand / ArmOzonebag Medium Foot / Leg
- Model / reference
- OZONE BAG, ATPVSO3AM
- Primary DI / UDI-DI
- 08683161110461
- Basic UDI-DI
- 868316111OZONBAG27, B-08683161110461
- Direct marketing DI
- 08683161110461
- EMDN code
- Z12019003 Wound treatment equipment
- Device class
- Class IIb
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- TR-MF-000016889
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