Identity
- Trade Name
- Helix Test EUDAMED
- Device Name
- Helix Test EUDAMED
- Model / Reference
- 35362 EUDAMEDT800206X EUDAMEDT800207X EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E308T800206X0F EUDAMED+E308T800207X0G EUDAMED
- Basic UDI-DI
- ++E30835362GJ EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - 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
Category: Sterilizer/disinfector rack
Helix Test by W&H Sterilization Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++E30835362GJ | Class I | Active |
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Manufacturer
- Manufacturer
- W&H Sterilization Srl
- EUDAMED SRN
- IT-MF-000008237
Sources (2)
- EUDAMED 0aa34f90-b426-4c0c-b385-7976a0cfdd13 61 fields · synced Sep 18, 2026
- EUDAMED 8b451023-3697-45fb-9ced-59f450f946f5 61 fields · synced May 19, 2026