UDI, listing & traceability by country

submissionSurface: EUDAMED plus Austrian national/special purpose registration and forms · verifiedHighlights: BASG verifies Austrian EUDAMED actor registration requests.; The page reflects mandatory EUDAMED actor/device use from 28 May 2026.

submissionSurface: EUDAMED for covered actors/devices; FAMHP web portal for national distributor obligations · verifiedHighlights: Belgian distributors remain subject to national FAMHP portal registration.; The current page distinguishes EUDAMED importer registration from national distributor registration.

Before placing a device on the market, the manufacturer must assign a UDI to the device and, where applicable, to higher packaging levels under the rules of an ANVISA designated issuing entity.

model specific UDI DI; production identifier UDI PI; UDI carrier on the label or device and higher packaging levels; record retention by manufacturers and economic operators; ANVISA UDI database

submissionSurface: EUDAMED plus Danish national distributor/specialty retailer registration form · verifiedHighlights: From 28 May 2026, covered manufacturers, authorised representatives and importers register in EUDAMED.; Danish distributors and specialty retailers retain national registration duties.

submissionSurface: EUDAMED mandatory layer plus DMIDS transitional/special workflows · verifiedHighlights: BfArM publishes DMIDS access forms, instructions and special authorisation workflows.; The page documents the 28 May 2026 EUDAMED transition and states that automatic DMIDS transfer is unavailable.

submissionSurface: EUDAMED plus EOF national medical device register/forms for applicable national duties · verifiedHighlights: EOF publishes current medical device supporting documents and forms.; EOF separately maintains medical device notification, vigilance and distribution/production materials.

submissionSurface: EUDAMED shared layer plus Italian BD/RDM national database workflows · verifiedHighlights: The Ministry publishes national database access, delegation, modification and help materials.; The same official hub exposes UDI, vigilance, import/export and open device data surfaces.

submissionSurface: EUDAMED plus Liechtenstein notifications/forms for national and customs union edge cases · verifiedHighlights: The official page maps EEA MDR/IVDR registration to EUDAMED.; It separately describes custom made and IVD notifications and Liechtenstein's parallel EEA/Swiss market access context.

submissionSurface: EUDAMED plus NOTIS for custom made and transition specific national notifications · verifiedHighlights: Farmatec's current page reflects mandatory EUDAMED device registration from 28 May 2026.; Custom made device and transition specific changes remain in NOTIS.

submissionSurface: EUDAMED · verifiedHighlights: Norway implements the EU device regulations through the EEA and now uses EUDAMED for device registration.; The official page includes the 28 November 2026 transition deadline for earlier devices.

submissionSurface: EUDAMED plus current URPL national forms/notifications for specified routes · verifiedHighlights: URPL publishes four current device forms and filling instructions.; The official page distinguishes EUDAMED actor/device registration from remaining national notifications.

submissionSurface: EUDAMED shared layer plus INFARMED national licensing/notification surfaces · verifiedHighlights: INFARMED's official hub links device registration, licensing, guidance and searchable national device data. · caveat: Some national transition wording predates mandatory EUDAMED modules and requires a current delta check.

submissionSurface: EUDAMED plus ANMDMR national database forms and email/physical filing · verifiedHighlights: ANMDMR publishes Word/PDF forms for devices, IVDs, custom made devices and information changes.; The authority explicitly states that national database registration is not product approval.

submissionSurface: EUDAMED shared layer plus JAZMP/SPOT national registration and forms · verifiedHighlights: JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigation and free sale certificates.; The current national basis includes the Medical Devices Act ZMedPri 1.

submissionSurface: EUDAMED plus RECOPS national commercialization registration from 15 June 2026 · verifiedHighlights: AEMPS launched RECOPS on 15 June 2026 and ended new filings in the former CCPS/RPS routes except specified custom made workflows.; RECOPS receives Spanish market commercialization information including labels and instructions.

submissionSurface: EUDAMED for covered roles plus Swedish MPA registration for specified national categories · verifiedHighlights: The June 2026 update maps each actor/device category to EUDAMED or the Swedish national system.; The page also describes data update and annual fee obligations for covered national roles.