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Sterile Infusion Set with or without needle
EUDAMEDClass IIa (EU MDR)
Ref 420-2138
Identity
- Device Name
- Sterile Infusion Set with or without needle EUDAMED
- Model / Reference
- 420-2138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62851000199450 EUDAMED
- Basic UDI-DI
- 62851420-2138VS EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Sterile Infusion Set with or without needle by Saudi Mais Co. For Medical products — 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 | 62851420-2138VS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saudi Mais Co. For Medical products
- EUDAMED SRN
- SA-MF-000025189
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 32c7efa7-32f6-421f-ad66-10531f850d8a 61 fields · synced Jul 23, 2026