Identity
- Trade Name
- Kiestra EUDAMEDBD Kiestra™ Corner FDA UDI
- Generic Name
- Laboratory container/microscope slide robotic transfer system IVD FDA UDI
- Device Name
- BD Kiestra Track Family EUDAMEDBD Kiestra™ Corner FDA UDI
- Model / Reference
- 446098 EUDAMEDFDA UDI
- Description
- BD Kiestra™ Corner FDA UDI
Identifiers
- Catalog Number
- 446098 FDA UDI
- Primary DI / UDI-DI
- 00382904460983 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290YDBYCJUGF2 EUDAMED
- Direct Marketing DI
- 00382904460983 EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W02039080 VARIOUS MICROBIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Laboratory container/microscope slide robotic transfer system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kiestra by BD Kiestra B.V. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290YDBYCJUGF2 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- BD Kiestra B.V.
- EUDAMED SRN
- NL-MF-000018863
Sources (2)
- EUDAMED 4867f3bb-9d7d-4067-9e85-3248e7fea429 61 fields · synced May 29, 2026
- FDA UDI f034dade-1dfc-48f6-a2f5-df64fe314eda 35 fields · synced May 29, 2026