Identity
- Trade Name
- ExactaMix EVA EUDAMED
- Device Name
- Parenteral Bags EUDAMED
- Model / Reference
- E1305OLPF5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18058159780532 EUDAMED
- Basic UDI-DI
- 805815978SPYV EUDAMED
- Unit of Use DI
- 08058159780535 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
- Belgium 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
ExactaMix EVA 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 87da5e4e-9b06-4221-80e6-5df0891a3779 61 fields · synced Jul 19, 2026