Identity
- Trade Name
- ONYX B 8.0 EUDAMED
- Device Name
- ONYX B 8.0 EUDAMED
- Model / Reference
- AB017ZXZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- E309AB017ZXZ0 EUDAMED
- Basic UDI-DI
- B-E309AB017ZXZ0 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
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
Onyx B 8.0 by Tecno-Gaz S.p.A — Class IIb — 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-E309AB017ZXZ0 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tecno-Gaz S.p.A
- EUDAMED SRN
- IT-MF-000010075
Sources (1)
- EUDAMED 75374285-d5f4-4239-b1b9-20b36892151c 61 fields · synced Jun 17, 2026