Identity
- Trade Name
- ATB™ DENSITOMETER CONTROL KIT EUDAMED
- Device Name
- ATB™ DENSITOMETER CONTROL KIT EUDAMED
- Model / Reference
- 15512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03573026040949 EUDAMED
- Basic UDI-DI
- 357302BUDI000212ST EUDAMED
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Multiple bacteria species culture isolate identification control IVD, kit
Atb™ Densitometer Control Kit by Biomerieux Sa — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 357302BUDI000212ST | Class A | Active |
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Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (1)
- EUDAMED 0246a531-91c5-450e-b674-e82387ed5c2a 61 fields · synced Jul 11, 2026