Identity
- Device Name
- ASPIFLEX EUDAMED
- Model / Reference
- ASPIFLEX EUDAMEDASP2096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055348434965 EUDAMED
- Basic UDI-DI
- 805534843FT04ASPCY EUDAMED
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Aspiflex by Meika Group S.r.l. — 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 | 805534843FT04ASPCY | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meika Group S.r.l.
- EUDAMED SRN
- IT-MF-000029106
Sources (1)
- EUDAMED 3698f247-95e2-4720-875c-04d47923f8ce 61 fields · synced Jun 19, 2026