StageOne (Neutral)
Ref INOV8-009
StageOne (Neutral) (INOV8-009) is a Class I device made by Meditech Endoscopy, Ltd., registered in EUDAMED on 31 Jan 2025 (Basic UDI-DI 5060602250031PG), active as of 7 Nov 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 | Number5060602250031PG 05060602250031 | Date31 Jan 2025 | StatusActive |
Official records
- EUDAMED public site 5060602250031PG
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- Withdrawn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
- Device name
- StageOne N
- Model / reference
- INOV8-009
- Primary DI / UDI-DI
- 05060602250031
- Basic UDI-DI
- 5060602250031PG
- EMDN code
- Z12011301 Cleaning and disinfection equipment
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000014143
- Authorised representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
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