Identity
- Trade Name
- KabiHelp Advance Plus LL EUDAMED
- Device Name
- Parenteral Bags EUDAMED
- Model / Reference
- F1402DFCA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18058159781720 EUDAMED
- Basic UDI-DI
- 805815978SPYV EUDAMED
- EMDN Code
- A080102 PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
KabiHelp Advance Plus LL by DIFFUPLAST srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805815978SPYV | Class I | Active |
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Manufacturer
- Manufacturer
- DIFFUPLAST srl
- EUDAMED SRN
- IT-MF-000022506
Sources (1)
- EUDAMED 5b427220-cfbc-4f9c-948d-59ca0d217ca8 61 fields · synced Jun 19, 2026