Reusable Medical Device UDI Plates and Data Matrix Tags
Reusable Medical Device UDI Plates and Data Matrix Tags
Custom metal UDI carriers for qualifying reusable medical devices and durable healthcare equipment, manufactured from customer-approved code data, drawings and validation requirements.
U.S. FDA regulations can require a permanent UDI marking on a device that must bear a UDI, is intended for repeated use and is intended to be reprocessed before each use. EU MDR and IVDR rules also include on-device UDI-carrier provisions for qualifying reusable devices. The device manufacturer determines the applicable rule, issuing-agency format, carrier type, attachment method and validation plan.
Request a UDI plate manufacturing quote →
Potential applications
- Reusable diagnostic and treatment equipment
- Medical carts, stands and durable equipment assemblies
- Sterilization and instrument-processing equipment
- Reusable accessories and device components large enough for an attached plate
- Replacement UDI or identification plaques specified by the legal manufacturer
Customer-controlled project requirements
Medical-device marking is validation-driven. The customer should specify the UDI issuing entity, code artwork or encoded data, readable text, device surface, cleaning and reprocessing exposure, expected life, attachment method and acceptance criteria. Stainless steel is available, but no single alloy, finish or adhesive is suitable for every clinical or sterilization environment.
Manufacturing options
| Feature | Available by specification |
|---|---|
| Carrier | Customer-supplied Data Matrix, barcode, QR code or readable UDI text |
| Plate material | 304 stainless, 316 stainless or aluminum |
| Mounting | Holes, customer-approved fasteners, adhesive or custom geometry |
| Data | Matching, sequential or fully variable records |
| Approval | Digital proof, prototype or first article before production |
What to send for a quote
- Device name, classification and destination markets
- Approved UDI carrier artwork or issuing-agency data
- Plate dimensions and permitted marking area
- Material, finish and attachment specification
- Cleaning, disinfecting or sterilization process information
- Readability, verification and lifetime acceptance criteria
- Quantities and variable-data file
Frequently asked questions
Are these FDA-approved UDI plates?
No. FDA does not approve a generic Custom Cutouts plate. We manufacture the physical carrier to the legal manufacturer's supplied specification.
Can a plaque be used as a UDI direct mark?
FDA guidance discusses a plaque or similar item attached to device hardware as one possible way to display information, including a UDI. Suitability must be determined and validated for the specific device.
Can you promise readability after sterilization?
No generic construction can make that promise. The customer must define the exposure and validation protocol; we can supply samples for testing.
Request a custom quote
Send the controlling specification, approved code data or artwork, quantity, material, dimensions, mounting requirements and acceptance criteria. We can quote prototypes, first articles, unique-code batches and recurring production.
Standard customer-supplied QR and Data Matrix tag formats
These existing listings are useful when a 1" × 3" format fits the project. They are physical customer-supplied-code tags and do not include Connected Metal Tags software. Contract-controlled work, specialized verification and custom layouts should be quoted.
Related identification resources
- EU battery passport QR plates
- EU digital product passport data carriers
- DoD IUID Data Matrix plates
- Reusable medical-device UDI plates
- Aerospace Data Matrix identification
- Construction-product DPP plates
References: FDA UDI direct-marking guidance and EU Medical Device Regulation.
Custom Cutouts manufactures physical identification plates from customer-supplied and customer-approved information. We do not assign regulatory identifiers, register records, select the governing requirements, certify a customer's product or guarantee that a generic layout satisfies a contract, regulation or technical standard. Final code content, placement, mounting, material, verification and approval remain the customer's responsibility.