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Aspiflex
EUDAMEDClass IIa (EU MDR)
Ref ASP4094Model ASPIFLEXRef COM0006Model COMPOFLEX
Identity
- Device Name
- ASPIFLEX EUDAMED08055348430264 EUDAMED
- Model / Reference
- ASPIFLEX EUDAMEDASP4094 EUDAMEDCOMPOFLEX EUDAMEDCOM0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055348434026 EUDAMED08055348430264 EUDAMED
- Basic UDI-DI
- 805534843FT04ASPCY EUDAMEDB-08055348430264 EUDAMED
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMEDA07050202 CAPS OR OBTURATORS, PERFORABLE WITHOUT NEEDLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805534843FT04ASPCY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805534843FT04ASPCY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meika Group S.r.l.
- EUDAMED SRN
- IT-MF-000029106
Sources (2)
- EUDAMED 7ef045c1-e21e-492e-85e4-d4f1902e09d0 61 fields · synced Sep 18, 2026
- EUDAMED 4be37055-26c3-4e37-89f8-9ae96a55d1f6 61 fields · synced Sep 18, 2026