Device Classification (LM_PMDA_DEVICE_CLASSIFICATION)
The Device Classification codelist is available in the Flexible Data Re-Categorization menu option.
The values are referred from the LM_PMDA_DEVICE_CLASSIFICATION table for the device license for the PMDA Device Classification 1, PMDA Device CLassification 2 and PMDA Device Classification 3 fields.
| Device Classification | Display |
|---|---|
|
High Level Controlled Medical Device (Class IV) |
Yes |
|
High Level Controlled Medical Device (Class III) |
Yes |
|
Controlled Medical Device |
Yes |
|
Generic Medical Device |
Yes |
|
Combination products (Drugs) |
Yes |
|
Stand-alone software (Class IV) |
Yes |
|
Stand-alone software (Class III) |
Yes |
|
Stand-alone software (Class II) |
Yes |
|
Combination products (Tissue-Engineered Medical Products) |
No |
|
Biogenous |
Yes |
|
Specific Biogenous |
Yes |
|
Other |
Yes |
|
Single Use Medical Device |
Yes |
|
Reiteration Use Medical Device |
Yes |
Parent topic: Flexible Data Re-Categorization