Identity
- Trade Name
- ROMA Charger EUDAMEDFDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- Charger EUDAMEDROMA Charger FDA UDI
- Model / Reference
- ACC000066 EUDAMEDFDA UDI
- Description
- ROMA Charger FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530795 EUDAMEDFDA UDI
- Basic UDI-DI
- 803392853CHAJG EUDAMED
- Direct Marketing DI
- 08033928530795 EUDAMED
- FDA Product Code
- KSD FDA UDI
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
- GMDN Term
- Blood donor bag tube divider/sealer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9750 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ROMA Charger 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 | 803392853CHAJG | 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 d5c3bb49-9447-48ab-93f1-f2c020e8bc49 61 fields · synced Jul 28, 2026
- FDA UDI 47cb82d3-50e0-4a58-acc1-1ff5e3f770b8 33 fields · synced May 30, 2026