Identity
- Device Name
- RedQal Group EUDAMED
- Model / Reference
- RedQal EUDAMED190045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760369291187 EUDAMED
- Basic UDI-DI
- B-03760369291187 EUDAMED
- EMDN Code
- W0103030999 COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
RedQal Group by Etablissement Francais Du Sang — Class IVD Annex II List A — 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-03760369291187 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Etablissement Francais Du Sang
- EUDAMED SRN
- FR-MF-000013221
Sources (1)
- EUDAMED b2186ff5-b33a-4d16-bcd0-82340475efe0 61 fields · synced Oct 6, 2026