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Kiestra

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 447206

by BD Kiestra B.V.

Identity

Trade Name
Kiestra EUDAMED
BD Kiestra™ ReadA™ Compact FDA UDI
Generic Name
Microbial incubator/imaging system IVD FDA UDI
Device Name
BD Kiestra™ ReadA™ Compact BD Kiestra™ ReadA EUDAMED
BD Kiestra™ ReadA™ Compact FDA UDI
Model / Reference
447206 EUDAMEDFDA UDI
Description
BD Kiestra™ ReadA™ Compact FDA UDI

Identifiers

Catalog Number
447206 FDA UDI
Primary DI / UDI-DI
00382904472061 EUDAMEDFDA UDI
Basic UDI-DI
038290NJLELBHF8B EUDAMED
Direct Marketing DI
00382904472061 EUDAMED
FDA Product Code
JTQ FDA UDI
EMDN Code
W02039002 CARBON DIOXIDE INCUBATORS EUDAMED
GMDN Term
Microbial incubator/imaging system IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
866.2540 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

Dimensions & Sizes

Size
Width — 1000 Millimeter FDA UDI
Height — 2300 Millimeter FDA UDI
Depth — 1640 Millimeter FDA UDI

Category: Automated laboratory incubator

Kiestra by BD Kiestra B.V. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automated laboratory incubator.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BD Kiestra B.V.
EUDAMED SRN
NL-MF-000018863

Sources (2)

  • EUDAMED 9268e33f-5591-4234-a610-2f12ed4e8982 61 fields · synced May 30, 2026
  • FDA UDI 80cd79c9-9e13-462e-b600-0c3976fb8c9e 37 fields · synced May 25, 2026