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Fractiomatic Plus 3 - WIFI Version
EUDAMEDClass I (EU MDR)
Ref FRA3.DB.WIFI
by Delcon Srl
Identity
- Trade Name
- Fractiomatic Plus 3 - WIFI Version EUDAMED
- Device Name
- Extractor EUDAMED
- Model / Reference
- FRA3.DB.WIFI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033928530405 EUDAMED
- Basic UDI-DI
- 803392853EXTRHR EUDAMED
- Direct Marketing DI
- 08033928530405 EUDAMED
- EMDN Code
- Z121799 BLOOD TRANSFUSION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Fractiomatic Plus 3 - WIFI 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 | 803392853EXTRHR | Class I | Active |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (1)
- EUDAMED 5c52c445-3306-4d92-9015-e7bff2e13cb9 61 fields · synced Jun 19, 2026