Appears in
Constraints
Unique key(s)
- Regulatory Device Identifier
Stereotype(s)
n/a
Attributes
| Attribute | Type | Multiplicity | Attribute note |
|---|---|---|---|
| Regulatory Device Identifier | Identifier | 1 | The part of the UDI identifying manufacturer and model.
Note: The device identifier (UDI-DI) is the mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The UDI-DI portion is placed on a device label or package. A device may include multiple UDI-DIs if it is sold in multiple jurisdictions. |
| Regulatory Device Identifier Jurisdiction URI | String | 0..1 | The URI of the regulatory authority governing the device UDI. |
| Regulatory Machine Readable UDI | Binary | 0..1 | Machine-readable representation of the device's UDI. |
| Regulatory Human Readable UDI | String | 0..1 | Plain text (human readable) representation of the device's UDI. |
| Regulatory Device UDI Entry Type Code | Codeable Concept | 0..1 | Uniquely specifies the method used to capture the Unique Device Identification (UDI).
Examples: barcode, RFID, manual, card, self-reported, electronic-transmission, unknown.
Value Set:
https://hl7.org/fhir/R4B/valueset-udi-entry-type.html |
Relationships
| From class | From multiplicity | Relationship | To class | To multiplicity |
|---|---|---|---|---|
| Device | 1 | has | Regulatory Device UDI | 0..* |
Contact us
If you have questions about this initiative, would like to be added to our stakeholder notification list or would like to participate in our consultations, please email us.
How to cite:
Canadian Institute for Health Information. Regulatory Device UDI. Accessed November 02, 2026.
