Identity
- Trade Name
- Kiestra EUDAMED
- Device Name
- BD Kiestra™ IdentifA BD Kiestra™ IdentifA TLA Connection BD Kiestra™ IdentifA WCA Connection BD Kiestra™ Isolate Suspension Cuvette Array BD Kiestra™ IdentifA Manual Infeed EUDAMED
- Model / Reference
- 444062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382904440626 EUDAMED
- Basic UDI-DI
- 038290IZCYQAPNK9 EUDAMED
- Direct Marketing DI
- 00382904440626 EUDAMED
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - 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 Becton, Dickinson and Company — 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 | 038290IZCYQAPNK9 | Class A | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (1)
- EUDAMED f8a873eb-c2ff-4e60-afcb-9f9141c173fe 61 fields · synced Oct 7, 2026