← Back to catalogue
Macopress Smart - WIFI BI Version
EUDAMEDFDA UDIClass I (EU MDR)
Ref MAC2.BI.WIFI
by Delcon Srl
Identity
- Trade Name
- Macopress Smart - WIFI BI Version EUDAMEDMacoPress Smarter FDA UDI
- Generic Name
- Blood component separator, automated FDA UDI
- Device Name
- Extractor EUDAMEDThe MacoPress Smarter (MPS) and DMS consist of two parts: the MacoPress Smarter device and the DMS Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed. FDA UDI
- Model / Reference
- MAC2.BI.WIFI EUDAMEDMacoPress Smart Smarter and DMS WIFI Module - with breaker module FDA UDI
- Description
- The MacoPress Smarter (MPS) and DMS consist of two parts: the MacoPress Smarter device and the DMS Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed. FDA UDI
Identifiers
- Catalog Number
- MAC2.BI.WIFI FDA UDI
- Primary DI / UDI-DI
- 08033928530276 EUDAMEDFDA UDI
- Basic UDI-DI
- 803392853EXTRHR EUDAMED
- Direct Marketing DI
- 08033928530276 EUDAMED
- FDA Product Code
- KSS FDA UDI
- EMDN Code
- Z121799 BLOOD TRANSFUSION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Blood component separator, automated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9050 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
Macopress Smart - WIFI BI 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 | 803392853EXTRHR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (2)
- EUDAMED f94d99bf-ce4e-4ed5-b587-5a1cdc2a7dc3 61 fields · synced Jul 26, 2026
- FDA UDI b298075c-cc09-44b4-b9c5-223768ab45b1 34 fields · synced May 30, 2026