Identity
- Device Name
- SEP8020 EUDAMED
- Model / Reference
- SEPLEX EUDAMEDSEP8020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055348433371 EUDAMED
- Basic UDI-DI
- B-08055348433371 EUDAMED
- EMDN Code
- A020102010102 INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sep8020 by Meika Group S.r.l. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08055348433371 | Class I | Active |
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Manufacturer
- Manufacturer
- Meika Group S.r.l.
- EUDAMED SRN
- IT-MF-000029106
Sources (1)
- EUDAMED a1d6d68a-d5bb-4e8a-a771-5f32ad1f90d9 61 fields · synced Jun 18, 2026