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ROMA Cordless handheld sealer for blood bag tubing and Charger
EUDAMEDClass I (EU MDR)
Ref HWONE.CORE.01
by Delcon Srl
Identity
- Trade Name
- ROMA Cordless handheld sealer for blood bag tubing and Charger EUDAMED
- Device Name
- Sealer EUDAMED
- Model / Reference
- HWONE.CORE.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033928530801 EUDAMED
- Basic UDI-DI
- 803392853SEALFP EUDAMED
- Direct Marketing DI
- 08033928530801 EUDAMED
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES 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
ROMA Cordless handheld sealer for blood bag tubing and Charger 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 | 803392853SEALFP | Class I | Active |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (1)
- EUDAMED e2f6afc9-a925-4edf-b75b-828ce55b5cd8 61 fields · synced Oct 6, 2026