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Maisfusion Set
EUDAMEDClass IIa (EU MDR)
Ref MI/CA/01-000-EModel IV Administration Set - Standard/Premium/With Y Injection Site/With Flow Regulator/With Three Way Stop Cock/With Micro Needle/With 0.2 Micron Filter/With Micro Needle (Vented & Non-Vented)
Identity
- Trade Name
- Maisfusion Set EUDAMED
- Device Name
- IV Administration Set EUDAMED
- Model / Reference
- IV Administration Set - Standard/Premium/With Y Injection Site/With Flow Regulator/With Three Way Stop Cock/With Micro Needle/With 0.2 Micron Filter/With Micro Needle (Vented & Non-Vented) EUDAMEDMI/CA/01-000-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906065481032 EUDAMED08906065481735 EUDAMED08906065489793 EUDAMED08904476800084 EUDAMED
- Basic UDI-DI
- 890606548I04LY EUDAMED
- Direct Marketing DI
- 08906065481032 EUDAMED08906065481735 EUDAMED08906065489793 EUDAMED08904476800084 EUDAMED
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia EUDAMEDLithuania EUDAMEDIreland EUDAMEDFrance 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Maisfusion Set by Mais India Medical Devices Pvt. Ltd. — Class IIa — 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 | 890606548I04LY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mais India Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000021842
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 2eca25d8-774c-418e-b0d8-f2cc0bfd18b4 61 fields · synced Oct 6, 2026
- EUDAMED 7058b400-a4d1-4e4c-99dd-0c1fcd3375f2 61 fields · synced May 17, 2026
- EUDAMED 13ac29ff-3e3c-4922-860b-59b6fc694a97 61 fields · synced May 19, 2026
- EUDAMED 1e75ae4b-ec8a-493d-aba2-91304de52a69 61 fields · synced May 19, 2026