Identity
- Trade Name
- Proteus OX2, 1 x 5 mL EUDAMED
- Device Name
- Proteus OX2, 1 x 5 mL EUDAMED
- Model / Reference
- 101-0636 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-084360388188182HZ EUDAMED
- Basic UDI-DI
- B-084360388188182HZ EUDAMED
- EMDN Code
- W0105011712 PROTEUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Proteus OX2, 1 x 5 mL by Chronolab Systems, S.L. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-084360388188182HZ | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chronolab Systems, S.L.
- EUDAMED SRN
- ES-MF-000017043
Sources (1)
- EUDAMED cd4793bf-4fa5-444a-96ab-ec08c2a4796c 61 fields · synced Jul 17, 2026