Identity
- Trade Name
- AURA X BLUE 22 EUDAMED
- Model / Reference
- STEAM STERILIZER EUDAMEDAB001ZPB EUDAMED
Identifiers
- Primary DI / UDI-DI
- E309AB001ZPB0 EUDAMED
- Basic UDI-DI
- ++E309AB001ZPB56 EUDAMED
- EMDN Code
- Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Aura X Blue 22 by Tecno-Gaz S.p.A — Class IIb — 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 | ++E309AB001ZPB56 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecno-Gaz S.p.A
- EUDAMED SRN
- IT-MF-000010075
Sources (1)
- EUDAMED 04664359-ee1c-4bec-aac1-c64d93c274e5 61 fields · synced Jun 18, 2026