Identity
- Trade Name
- DELCON X5 - Basic version EUDAMED
- Device Name
- Mixer EUDAMED
- Model / Reference
- HMIX4.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033928530511 EUDAMED
- Basic UDI-DI
- 803392853MIXEGQ EUDAMED
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DELCON X5 - Basic version by Delcon Srl — Class I — 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 | 803392853MIXEGQ | Class I | Active |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (1)
- EUDAMED d2bf6aad-e5ed-43a1-af4c-b33c541bcdc5 61 fields · synced Jul 12, 2026