| Primary Device ID | EPRCA1001520 |
| NIH Device Record Key | fd31733b-8821-4a36-81fa-1001e860cbd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | audioprint GR-11.1 I MSI |
| Version Model Number | 1kg - beige |
| Catalog Number | A1001520 |
| Company DUNS | 312947842 |
| Company Name | pro3dure medical GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com | |
| Phone | +4923749200500 |
| info@pro3dure.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EPRCA1001520 [Primary] |
| ESD | Hearing Aid, Air Conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-26 |
| Device Publish Date | 2023-10-18 |
| EPRC66100849 - dima Print Denture Base 2 | 2025-08-08 dima Print Denture Base 2 1kg - Original Pink |
| EPRC66100850 - dima Print Denture Base 2 | 2025-08-08 dima Print Denture Base 2 1kg - Reddish-Pink |
| EPRC0220001A2 - ACRY PRINT RU-001 Temporary | 2025-04-08 ACRY PRINT RU-001 Temporary 1000g A2 |
| EPRC0220001A3 - ACRY PRINT RU-001 Temporary | 2025-04-08 ACRY PRINT RU-001 Temporary 1000g A3 |
| EPRC0220003 - ACRY PRINT RU-003 Try-In | 2025-04-08 ACRY PRINT RU-003 Try-In 1000g A2 |
| EPRC0220004 - ACRY PRINT RU-004 Denture HI | 2025-04-08 ACRY PRINT RU-004 Denture HI 1000g Orange-Pink |
| EPRC0220005 - ACRY PRINT RU-005 Guide | 2025-04-08 ACRY PRINT RU-005 Guide 1000g Clear-Transparent |
| EPRC768345 - UCAN Print Base | 2025-04-08 UCAN Print Base 1000g color 33 |