Identity
- Trade Name
- Kiestra EUDAMEDBD Kiestra™ ReadA FDA UDI
- Generic Name
- Microbial incubator/imaging system IVD FDA UDI
- Device Name
- BD Kiestra™ ReadA™ Compact BD Kiestra™ ReadA EUDAMEDBD Kiestra™ ReadA FDA UDI
- Model / Reference
- 446948 EUDAMEDFDA UDI
- Description
- BD Kiestra™ ReadA FDA UDI
Identifiers
- Catalog Number
- 446948 FDA UDI
- Primary DI / UDI-DI
- 00382904469481 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290NJLELBHF8B EUDAMED
- Direct Marketing DI
- 00382904469481 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 EUDAMEDClass 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
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.
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- BIOSPAG-SI — Agilent Technologies Inc. · Class I
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 | 038290NJLELBHF8B | 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 802633ce-4e6d-4f91-b68f-76915245e793 61 fields · synced Jul 9, 2026
- FDA UDI 1b4fd117-5af0-4e93-a1b1-6db0ad013d52 36 fields · synced May 30, 2026