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Ethox, Infu‐Surg Clarity, 1000mL
EUDAMEDClass I (EU MDR)
Ref 4100Model Pressure Infusion Bags
Identity
- Trade Name
- Ethox, Infu‐Surg Clarity, 1000mL EUDAMED
- Model / Reference
- Pressure Infusion Bags EUDAMED4100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10889481621877 EUDAMED
- Basic UDI-DI
- B-10889481621877 EUDAMED
- EMDN Code
- A0599 MECHANICAL INFUSION SYSTEMS, SINGLE-USE - 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ethox, Infu‐Surg Clarity, 1000mL by Ethox Medical, Llc — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10889481621877 | Class I | Active |
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Manufacturer
- Manufacturer
- Ethox Medical, LLC
- EUDAMED SRN
- US-MF-000054305
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (1)
- EUDAMED a25268d4-35b2-4628-b2ae-9c5726300560 61 fields · synced Jun 18, 2026