Identity
- Trade Name
- AMSure® Enteral Feeding Gravity Spike Set EUDAMED
- Device Name
- Enteral Feeding set EUDAMED
- Model / Reference
- EFG501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10704411004233 EUDAMED
- Basic UDI-DI
- B-10704411004233 EUDAMED
- EMDN Code
- A03010301 ENTERAL FEEDING GRAVITY CONTROLLERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AMSure® Enteral Feeding Gravity Spike Set by Amsino International, Inc. — 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-10704411004233 | Class I | 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 0f677a48-4c70-4726-80ae-9f7aa483e738 61 fields · synced Jun 19, 2026