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Kiestra
EUDAMEDFDA 510(k)FDA UDIClass A (EU MDR)
Ref 447209Ref 447900Ref 447211Ref 446958Ref 447902Ref 447293Ref 447212Ref 447904Ref 447901Ref 447272Ref 447208510(k) K213280Ref 446972Ref 446945Ref 496125
Identity
- Trade Name
- Kiestra EUDAMEDBD Kiestra™ Standard Connector FDA UDI
- Generic Name
- Laboratory container/microscope slide robotic transfer system IVD FDA UDI
- Device Name
- BD Kiestra™ InoqulA EUDAMEDBD Kiestra™ ProceedA WCA,TLA 4,TLA 8,TLA 10,TLA 12 EUDAMEDBD Kiestra Track Family EUDAMEDBD Kiestra™ Standard Connector FDA UDI
- Model / Reference
- 447209 EUDAMED447900 EUDAMED447211 EUDAMED446958 EUDAMED447902 EUDAMED447293 EUDAMED447212 EUDAMED447904 EUDAMED447901 EUDAMED447272 EUDAMED447208 EUDAMED446945 EUDAMEDFDA UDI446972 EUDAMED496125 EUDAMED
- Description
- BD Kiestra™ Standard Connector FDA UDI
Identifiers
- Catalog Number
- 446945 FDA UDI
- Primary DI / UDI-DI
- 00382904472092 EUDAMED00382904479008 EUDAMED00382904472115 EUDAMED00382904469580 EUDAMED00382904479022 EUDAMED00382904472931 EUDAMED00382904472122 EUDAMED00382904479046 EUDAMED00382904479015 EUDAMED00382904472726 EUDAMED00382904472085 EUDAMED00382904469450 EUDAMEDFDA UDI00382904469726 EUDAMED00382904961251 EUDAMED
- Basic UDI-DI
- 038290LSUVLPKFPV EUDAMED038290IAVSLVOZEG EUDAMED038290YDBYCJUGF2 EUDAMED
- Direct Marketing DI
- 00382904472092 EUDAMED00382904479008 EUDAMED00382904472115 EUDAMED00382904469580 EUDAMED00382904479022 EUDAMED00382904472931 EUDAMED00382904472122 EUDAMED00382904479046 EUDAMED00382904479015 EUDAMED00382904472085 EUDAMED00382904469726 EUDAMED00382904469450 EUDAMED00382904961251 EUDAMED
- 510(k) Number
- K213280 FDA 510(k)
- FDA Product Code
- QQY FDA 510(k)JQP FDA UDI
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMEDW02039080 VARIOUS MICROBIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDW0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMEDW020305,W02039004 EUDAMED
- GMDN Term
- Laboratory container/microscope slide robotic transfer system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)Class I FDA UDI
- Legislation / Framework
- 21 CFR Part 866.2190 FDA 510(k)
- Regulation Number
- 866.2190 FDA 510(k)862.2100 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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 — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213280 | Class A | Active |
| 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 (16)
- EUDAMED 05f7484a-5b44-47ef-ad95-14a5739d6461 61 fields · synced Jul 30, 2026
- EUDAMED b7215c3d-1765-4be4-85fd-0c5e08bae626 61 fields · synced May 16, 2026
- EUDAMED 9b3c4491-4525-4bc3-807c-f938a1f4f914 61 fields · synced May 16, 2026
- EUDAMED a0cf38f8-8302-4741-a153-986ab171c7e4 61 fields · synced May 17, 2026
- EUDAMED 29431a76-d4ef-4571-a134-7494fc175d9b 61 fields · synced May 17, 2026
- EUDAMED 9e6d96cf-9af2-4de8-895c-ed1c07e96230 61 fields · synced May 17, 2026
- EUDAMED b683a03e-70e1-4b3c-b8d1-984df7b887c1 61 fields · synced May 17, 2026
- EUDAMED 92aa58ed-34be-4420-8eaf-0b25b037ac6b 61 fields · synced May 18, 2026
- EUDAMED 58843298-630d-4059-8bc0-8645cf95c6b7 61 fields · synced May 18, 2026
- EUDAMED eec9082c-187f-4f62-9c84-2beac326eeb2 61 fields · synced May 18, 2026
- EUDAMED 0c6d680a-e4ec-43fd-9eb7-876357e58d97 61 fields · synced May 18, 2026
- FDA 510(k) K213280 24 fields · synced May 18, 2026
- FDA UDI dd580c5f-8b5b-4650-90b1-83cc2ed6a9aa 35 fields · synced May 30, 2026
- EUDAMED 0d094002-1f83-45c5-8436-e75b76f44d5c 61 fields · synced Jul 9, 2026
- EUDAMED 11541d87-a76e-44e5-9dde-88776fd0eb0c 61 fields · synced Jul 17, 2026
- EUDAMED 74518660-1be6-4bef-bab0-9ef0d3d891b1 61 fields · synced Jul 30, 2026