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Primefusion 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
- Primefusion 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
- 08906065481162 EUDAMED
- Basic UDI-DI
- 890606548I04LY EUDAMED
- Direct Marketing DI
- 08906065481162 EUDAMED
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Primefusion 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 (1)
- EUDAMED c4e232a4-14b4-4457-a7f5-a5b9faf7212f 61 fields · synced Jun 19, 2026