Identity
- Trade Name
- COR EUDAMEDBD COR™ MX FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- BD COR™ MX Instrument EUDAMEDBD COR™ MX FDA UDI
- Model / Reference
- 443989 EUDAMEDFDA UDI
- Description
- BD COR™ MX FDA UDI
Identifiers
- Catalog Number
- 443989 FDA UDI
- Primary DI / UDI-DI
- 00382904439897 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290PAODHOBV77 EUDAMED
- 510(k) Number
- K210585 FDA UDI
- FDA Product Code
- LSL FDA UDIMKZ FDA UDIOUY FDA UDIQEP FDA UDI
- EMDN Code
- W0201030182 MIXED PANEL MULTIPARAMETER ANALYSERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3390 FDA UDI866.3120 FDA UDI866.3860 FDA UDI866.3393 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cor by Becton, Dickinson and Company — 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 | 038290PAODHOBV77 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED b97feca2-3ea3-47fc-a1b3-fcf35e109145 61 fields · synced Oct 6, 2026
- FDA UDI b1af42f8-9a14-4f45-b11a-f4bff20f71e4 37 fields · synced May 30, 2026