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Ottix Shaper 5 Lt
EUDAMEDClass A (EU MDR)
Ref X0096Model XYLENE AND ALCOHOLS SUBSTITUTE - OTTIX SHAPER
Identity
- Trade Name
- OTTIX SHAPER 5 LT EUDAMED
- Device Name
- OTTIX SHAPER EUDAMED
- Model / Reference
- XYLENE AND ALCOHOLS SUBSTITUTE - OTTIX SHAPER EUDAMEDX0096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033895012577 EUDAMED
- Basic UDI-DI
- 8033895W01030799OttixSQ7 EUDAMED
- Direct Marketing DI
- 08033895012577 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Ottix Shaper 5 Lt by Diapath S.p.A. società a socio unico — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8033895W01030799OttixSQ7 | Class A | Active |
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Manufacturer
- Manufacturer
- Diapath S.p.A. società a socio unico
- EUDAMED SRN
- IT-MF-000027016
Sources (1)
- EUDAMED 997a019b-448d-4803-8b5a-7702d78db369 61 fields · synced Oct 7, 2026