Identity
- Trade Name
- Kiestra EUDAMED
- Device Name
- BD Kiestra™ InoqulA EUDAMED
- Model / Reference
- 447210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382904472108 EUDAMED
- Basic UDI-DI
- 038290LSUVLPKFPV EUDAMED
- Direct Marketing DI
- 00382904472108 EUDAMED
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Kiestra by BD Kiestra B.V. — Class A — 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 | 038290LSUVLPKFPV | Class A | Active |
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Manufacturer
- Manufacturer
- BD Kiestra B.V.
- EUDAMED SRN
- NL-MF-000018863
Sources (1)
- EUDAMED 94b38c69-d436-4ed0-b86a-79645d11bc0f 61 fields · synced May 23, 2026