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AMT MiniONE Enteral Extension Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref E4-0005-ISOSAF
Identity
- Trade Name
- AMT MiniONE Enteral Extension Set EUDAMED
- Device Name
- AMT Replacement Adapter EUDAMED
- Model / Reference
- E4-0005-ISOSAF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842071133566 EUDAMED
- Basic UDI-DI
- 08420711YPORTMM EUDAMED
- EMDN Code
- G020299 GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AMT MiniONE Enteral Extension Set by Applied Medical Technology, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142989 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08420711YPORTMM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
- EUDAMED SRN
- US-MF-000041414
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2b1df25b-5622-4a3e-a6b0-b1b735c139e4 61 fields · synced Oct 5, 2026
- FDA 510(k) K142989 1 fields · synced May 18, 2026