Identity
- Trade Name
- StageOne (Neutral) EUDAMED
- Device Name
- StageOne N EUDAMED
- Model / Reference
- INOV8-009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060602250031 EUDAMED
- Basic UDI-DI
- 5060602250031PG EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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: Surgical utensil washer/disinfector
StageOne (Neutral) by Meditech Endoscopy Limited — 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 | 5060602250031PG | Class I | Active |
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Manufacturer
- Manufacturer
- Meditech Endoscopy Limited
- EUDAMED SRN
- GB-MF-000014143
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (1)
- EUDAMED b99b6a52-b0fe-43e5-932f-72db973054f2 61 fields · synced Jul 16, 2026