Identity
- Trade Name
- AMSINO Burette Set EUDAMED
- Device Name
- Infusion Set with Burette EUDAMED
- Model / Reference
- AP2089-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10704411018384 EUDAMED
- Basic UDI-DI
- B-10704411018384 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - 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 Burette 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-10704411018384 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International Inc.
- EUDAMED SRN
- US-MF-000007234
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 79868bf3-0c3e-44c7-b490-e59d18bbe7db 61 fields · synced Aug 1, 2026