Identity
- Model / Reference
- AIR-X EUDAMEDKK84235.0A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057147000075 EUDAMED
- Basic UDI-DI
- 8057147FUP001T4 EUDAMED
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Kk84235.0a by Univet Loupes Spa — Class I — 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 | 8057147FUP001T4 | Class I | Active |
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Manufacturer
- Manufacturer
- Univet Loupes Spa
- EUDAMED SRN
- IT-MF-000027104
Sources (1)
- EUDAMED bb8e92ab-eea0-4aea-8683-4753d736e707 61 fields · synced Oct 1, 2026