tracekey UDI Manager
tracekey solutions GmbH
tracekey solutions GmbH offers the mytracekey UDI Manager, a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework. They focus on simplifying compliance with EU regulations.
tracekey solutions GmbH provides the mytracekey UDI Manager, a comprehensive software solution tailored for medical device manufacturers navigating the complexities of UDI (Unique Device Identification) registration within the EUDAMED database. Their offering emphasizes simplifying the process of data collection, processing, and pre-validation to ensure compliance with stringent EU regulations. The mytracekey UDI Manager assists manufacturers in pre-validating their master data before submission to EUDAMED. This proactive approach helps identify and correct potential errors, such as incorrect formatting, misplaced digits, or missing information, thereby reducing the risk of upload failures and the time-consuming detective work often associated with EUDAMED error messages. The tool supports various upload methods, including manual entry, XML bulk upload, and M2M connections, adapting to different project needs. With a focus on making compliance intuitive and efficient, tracekey solutions GmbH aims to empower companies in the healthcare sector to meet global regulatory requirements without hindering innovation. Their solutions are designed to be scalable and cost-effective, ensuring that regulatory adherence is manageable and precise for each client's specific needs. They are based in Germany, emphasizing transparency and high standards in their services.
About
**Who they are**
tracekey UDI Manager, offered by tracekey solutions GmbH, is a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework.
**Expertise & scope**
* Simplifies compliance with EU regulations for medical device manufacturers.
* Focuses on the EUDAMED Actor Registration Module, which is the first of six modules to be made publicly available.
* Assists with the registration of various EUDAMED Actor Roles, including manufacturers, authorized representatives, system and procedure pack producers, and importers, who receive a Single Registration Number (SRN).
* Supports the UDI module, the central component of EUDAMED, requiring manufacturers to input product information for transparency and traceability.
* Facilitates data pre-validation to ensure data quality and compliance with EUDAMED's business rules.
* Explains different methods for UDI data upload into EUDAMED, including manual entry, XML bulk upload (up to 300 products at a time), and Machine-to-Machine (M2M) connections.
* Addresses common errors that can occur during data entry and provides insights into preventing and fixing them.
* Differentiates between EU-UDI and US-UDI systems, highlighting differences in compliance dates, product classification, databases used, and required product data.
* Explains the concept of Basic UDI-DI introduced with EU MDR and EUDAMED.
**Reputation / proof points**
* Coverage: EU
tracekey UDI Manager, offered by tracekey solutions GmbH, is a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework.
**Expertise & scope**
* Simplifies compliance with EU regulations for medical device manufacturers.
* Focuses on the EUDAMED Actor Registration Module, which is the first of six modules to be made publicly available.
* Assists with the registration of various EUDAMED Actor Roles, including manufacturers, authorized representatives, system and procedure pack producers, and importers, who receive a Single Registration Number (SRN).
* Supports the UDI module, the central component of EUDAMED, requiring manufacturers to input product information for transparency and traceability.
* Facilitates data pre-validation to ensure data quality and compliance with EUDAMED's business rules.
* Explains different methods for UDI data upload into EUDAMED, including manual entry, XML bulk upload (up to 300 products at a time), and Machine-to-Machine (M2M) connections.
* Addresses common errors that can occur during data entry and provides insights into preventing and fixing them.
* Differentiates between EU-UDI and US-UDI systems, highlighting differences in compliance dates, product classification, databases used, and required product data.
* Explains the concept of Basic UDI-DI introduced with EU MDR and EUDAMED.
**Reputation / proof points**
* Coverage: EU
Additional information
tracekey UDI Manager supports manufacturers in navigating the complexities of EUDAMED UDI registration. The solution emphasizes pre-validation of master data to minimize errors before submission. Manufacturers can choose from manual entry, XML bulk upload, or M2M connections for data submission. The service highlights the importance of accurate data input, noting that human error is a common source of issues. By offering pre-validation, tracekey aims to reduce the time and effort manufacturers spend on rectifying errors and ensuring compliance with EUDAMED's business rules.
Key Highlights
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Offers a specialized software solution, mytracekey UDI Manager, for EUDAMED UDI registration and master data pre-validation.
Source
“tracekey solutions GmbH offers the mytracekey UDI Manager, a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework.”
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Explains EUDAMED Actor Roles and the importance of obtaining a Single Registration Number (SRN).
Source
“The EUDAMED Actor Roles are part of the Actor Registration Module. It is the first of the six modules to be made available to the public.”
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Details different methods for uploading UDI data into EUDAMED, including manual entry, XML bulk upload, and M2M connections.
Source
“There are three possibilities to upload data into EUDAMED: The manual entry, the XML bulk upload, and the M2M connection.”
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Addresses common errors in UDI data submission and provides methods for prevention and correction.
Source
“If you try to upload faulty data into EUDAMED, you will promptly receive an error message. There can be several reasons that trigger this.”
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Differentiates between EU-UDI and US-UDI systems, noting variations in compliance dates, product classification, and databases.
Source
“The Unique Device Identifier (UDI) in the EU and the US differs in some points.”
Certifications & Trust Signals
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Focuses on compliance with EU regulations for medical devices.
Source
“They focus on simplifying compliance with EU regulations.”
Buyer Snapshot
Best for
- Medical device manufacturers needing to comply with EUDAMED UDI registration requirements.
- Companies seeking to streamline their UDI data submission process.
How engagement typically works
- Software solution for self-service or assisted registration.
- Focus on data pre-validation and error reduction.
Typical deliverables
- Software for UDI data management and pre-validation.
- Guidance on EUDAMED Actor Registration.
- Support for various data upload methods (XML, M2M).
Good to know
- Best when manufacturers have a clear understanding of their product data and regulatory requirements.
HQ:
Bochum, DE
Languages:
English, German
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, ES, AT, NL, DK, DE
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–30 days
Pricing model:
Usage-based
Starting from:
EUR 800
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eudamed_onboarding_support
eudamed_m2m
Jurisdictions:
EU
Countries:
DE, FR, GB
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
The process involves collecting and processing product data, then choosing an upload method (manual, XML bulk, or M2M) to enter data into EUDAMED. Pre-validation of master data is recommended to ensure data quality and compliance.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor Registration, UDI/Devices
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
false
Supports Clinical Investigations
false
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