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AMSure® Enteral Delivery Set with Two 1200mL Bag
EUDAMEDClass IIa (EU MDR)
Ref EFPD1212
Identity
- Trade Name
- AMSure® Enteral Delivery Set with Two 1200mL Bag EUDAMED
- Device Name
- Enteral Delivery Pump set EUDAMED
- Model / Reference
- EFPD1212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10704411015895 EUDAMED
- Basic UDI-DI
- B-10704411015895 EUDAMED
- EMDN Code
- A080101 ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE 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
AMSure® Enteral Delivery Set with Two 1200mL Bag 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-10704411015895 | 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 5e7ff01e-c8f0-4c86-aeae-b358984fd9f9 61 fields · synced Jul 9, 2026