Identity
- Trade Name
- Rose Bengal, 100 tests EUDAMED
- Device Name
- Rose Bengal, 100 tests EUDAMED
- Model / Reference
- 101-0545 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-084360387397395JZ EUDAMED
- Basic UDI-DI
- B-084360387397395JZ EUDAMED
- EMDN Code
- W0105011701 BRUCELLA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Rose Bengal, 100 tests 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-084360387397395JZ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chronolab Systems, S.L.
- EUDAMED SRN
- ES-MF-000017043
Sources (1)
- EUDAMED a67b9413-7383-487b-8211-f1fe0f5f32e1 61 fields · synced Jul 25, 2026