Identity
- Device Name
- Set per irrigazione urologica EUDAMED
- Model / Reference
- UROFLEX EUDAMEDURO0097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055348433081 EUDAMED
- Basic UDI-DI
- B-08055348433081 EUDAMED
- EMDN Code
- A03010202 UROLOGICAL IRRIGATION CONTROLLERS 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
Set per irrigazione urologica 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-08055348433081 | Class I | Active |
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Manufacturer
- Manufacturer
- Meika Group S.r.l.
- EUDAMED SRN
- IT-MF-000029106
Sources (1)
- EUDAMED a8347ae7-c26b-447b-80b4-5efe9a500284 61 fields · synced Jun 18, 2026