← Back to catalogue
ACTIVE® Androstenedione RIA
EUDAMEDClass B (EU MDR)
Ref DSL3800Model Immunoassay, DSL3800
Identity
- Trade Name
- ACTIVE® Androstenedione RIA EUDAMED
- Device Name
- ACTIVE® Androstenedione RIA EUDAMED
- Model / Reference
- Immunoassay, DSL3800 EUDAMEDDSL3800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590211516 EUDAMED
- Basic UDI-DI
- 150995905DSL3800FG EUDAMED
- EMDN Code
- W0102050101 ANDROSTENEDIONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Czechia 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
ACTIVE® Androstenedione RIA by IMMUNOTECH s.r.o. — Class B — 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 | 150995905DSL3800FG | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (1)
- EUDAMED 86a5c6e5-461b-40c4-9b76-dd26af655850 61 fields · synced Jul 11, 2026