Identity
- Trade Name
- AMSINO Adult Non-Vented Blood Set EUDAMED
- Device Name
- Blood Transfusion Set EUDAMED
- Model / Reference
- AS2112R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10704411018919 EUDAMED
- Basic UDI-DI
- B-10704411018919 EUDAMED
- EMDN Code
- B99 HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AMSINO Adult Non-Vented Blood Set by Amsino International, Inc. — Class IIa — 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-10704411018919 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amsino International Inc.
- EUDAMED SRN
- US-MF-000007234
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 57f30cb6-86ed-46d7-8325-8ae832fe3306 61 fields · synced Jul 8, 2026