Identity
- Device Name
- Blood Transfusion Set with needle EUDAMED
- Model / Reference
- IS2101TH-G_NST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10704411020080 EUDAMED
- Basic UDI-DI
- B-10704411020080 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
Blood Transfusion Set with needle 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-10704411020080 | 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 1da51e08-df98-4a57-b881-b56ccfb6555c 61 fields · synced Jul 8, 2026