Identity
- Trade Name
- ACVB-Set EUDAMED
- Device Name
- ACVB-Set EUDAMED
- Model / Reference
- 66806578-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393809045 EUDAMED
- Basic UDI-DI
- 4034393CPTCAR3Q9 EUDAMED
- EMDN Code
- C0601 CARDIOVASCULAR SURGERY INSTRUMENT KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for cardiac, thoracic, hybrid or vascular disease treatment. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
ACVB-Set by Sengewald Klinikprodukte GmbH — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4034393CPTCAR3Q9 | Class III | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED 119b5a77-9ce8-459f-a30f-f8424eee4b73 61 fields · synced Aug 3, 2026