Helix Test
Ref T800206X, T800207XModel 35362
Helix Test (T800206X) is a medical device (EU MDR Class I; EMDN category sterilisation devices (excluding cat. d - z)) made by W&H Sterilization Srl, registered in EUDAMED on 19 Jan 2024 (Basic UDI-DI ++E30835362GJ), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++E30835362GJ | Date19 Jan 2024 | StatusActive |
Official records
- EUDAMED public site ++E30835362GJ
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 35362, T800206X, T800207X
- Primary DI / UDI-DI
- +E308T800206X0F, +E308T800207X0G
- Basic UDI-DI
- ++E30835362GJ
- EMDN code
- S9099 Sterilisation devices (excluding cat. d - z) - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000008237
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