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HemoMix 3 - LAN version
EUDAMEDFDA UDIClass I (EU MDR)
Ref HMIX3.LAN
by Delcon Srl
Identity
- Trade Name
- HemoMix 3 - LAN version EUDAMEDHemoMix 3 FDA UDI
- Generic Name
- Blood donation rocker FDA UDI
- Device Name
- Mixer EUDAMEDHemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Version with LAN option installed) FDA UDI
- Model / Reference
- HMIX3.LAN EUDAMEDFDA UDI
- Description
- HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Version with LAN option installed) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530030 EUDAMEDFDA UDI
- Basic UDI-DI
- 803392853MIXEGQ EUDAMED
- Direct Marketing DI
- 08033928530030 EUDAMED
- FDA Product Code
- MYJ FDA UDI
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
- GMDN Term
- Blood donation rocker FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9195 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HemoMix 3 - LAN version by Delcon Srl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803392853MIXEGQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (2)
- EUDAMED 1d955276-4cf3-4d2a-b188-373c87f46c25 61 fields · synced Jul 12, 2026
- FDA UDI 25f1ba10-9680-4242-ad20-aa44533734a0 34 fields · synced May 29, 2026