tracekey (mytracekey UDI Manager)
tracekey solutions GmbH
mytracekey UDI Manager supports UDI data management for EUDAMED, GUDID, Swissdamed, and AusUDID, with database-specific validation plus XML bulk upload and direct M2M submission options.
tracekey solutions GmbH provides mytracekey UDI Manager, cloud software for managing, validating, and submitting medical device UDI data. The platform supports workflows for EUDAMED, GUDID, Swissdamed, and AusUDID. For EUDAMED, it validates customer data against the applicable business rules and supports XML bulk upload or a direct machine-to-machine connection. tracekey does not perform manual entry in the EUDAMED interface or complete Actor/SRN registration for economic operators. It is a software provider rather than a consulting firm and collaborates with specialist partners when consulting support is needed.
About
**Who they are**
tracekey solutions GmbH provides mytracekey UDI Manager, cloud software for managing and submitting medical device UDI master data.
**Product scope**
* Supports UDI workflows for EUDAMED, GUDID, Swissdamed, and AusUDID.
* Validates customer data against database-specific business rules, including EUDAMED business rules.
* Supports EUDAMED submissions through XML bulk upload and a direct machine-to-machine (M2M) connection.
* Publishes regulatory guidance on EUDAMED modules, upload options, M2M, Swissdamed, and AusUDID.
**Scope boundaries**
* Does not perform manual data entry in the EUDAMED interface.
* Economic operators complete their own EUDAMED Actor registration and obtain their Single Registration Number (SRN).
* Does not provide consulting services; tracekey collaborates with specialist partners when consulting support is needed.
tracekey solutions GmbH provides mytracekey UDI Manager, cloud software for managing and submitting medical device UDI master data.
**Product scope**
* Supports UDI workflows for EUDAMED, GUDID, Swissdamed, and AusUDID.
* Validates customer data against database-specific business rules, including EUDAMED business rules.
* Supports EUDAMED submissions through XML bulk upload and a direct machine-to-machine (M2M) connection.
* Publishes regulatory guidance on EUDAMED modules, upload options, M2M, Swissdamed, and AusUDID.
**Scope boundaries**
* Does not perform manual data entry in the EUDAMED interface.
* Economic operators complete their own EUDAMED Actor registration and obtain their Single Registration Number (SRN).
* Does not provide consulting services; tracekey collaborates with specialist partners when consulting support is needed.
Additional information
Customers manage and validate their UDI master data in mytracekey UDI Manager, then submit EUDAMED data by generating XML bulk-upload files or using the direct M2M connection. Optional compliance modules extend the workflow to GUDID, Swissdamed, and AusUDID. tracekey also publishes articles and guides covering EUDAMED modules, submission methods, M2M, Swissdamed, and AusUDID.
Key Highlights
-
Supports UDI data management across EUDAMED, GUDID, Swissdamed, and AusUDID.
Source
“The product supports global regulatory databases including EUDAMED, GUDID, Swissdamed, and AusUDID.”
-
Validates UDI data against database-specific business rules before submission.
Source
“The software validates UDI master data against database-specific business rules.”
-
Supports EUDAMED XML bulk upload and direct M2M submission.
Source
“Validated data can be submitted by XML bulk upload or a direct M2M connection.”
-
Publishes guidance on EUDAMED modules, upload methods, M2M, Swissdamed, and AusUDID.
Source
“The EUDAMED and UDI FAQ covers modules, XML bulk upload, M2M, and cross-market use.”
Buyer Snapshot
Best for
- Medical device manufacturers managing UDI data for EUDAMED and other regulatory databases.
- Teams that want automated validation against database-specific business rules before submission.
- Organizations that need XML bulk upload or direct M2M submission for EUDAMED.
How engagement typically works
- Software-as-a-Service platform for UDI master data management and regulatory submissions.
- Customer data is validated before XML files are generated or records are sent through M2M.
- Specialist consulting needs can be handled through tracekey partner collaborations.
Typical deliverables
- mytracekey UDI Manager software access.
- Validation against EUDAMED business rules.
- EUDAMED XML bulk-upload files.
- Direct EUDAMED M2M connection.
- Optional GUDID, Swissdamed, and AusUDID compliance modules.
- Regulatory articles and guides on UDI database requirements and submission methods.
Good to know
- Manual entry in the EUDAMED interface is not provided.
- Economic operators are responsible for their own EUDAMED Actor registration and SRN.
- Consulting services are provided through specialist partners rather than directly by tracekey.
HQ:
Bochum, Germany
Languages:
German
Timezones:
UTC+1
Claim status:
Claimed
Services & Capabilities
EUDAMED M2M Integration
Included services:
UDI master data management, EUDAMED business-rules validation, XML bulk upload, Direct M2M connection, GUDID compliance module, Swissdamed compliance module, AusUDID compliance module
Supported Modules:
UDI/Devices
Submission Methods:
XML bulk upload, Direct M2M connection
Validates Against Business Rules:
Yes
Regulatory Databases:
EUDAMED, GUDID, Swissdamed, AusUDID
Manual EUDAMED Entry:
No
Actor Registration Support:
No
Consulting Services:
No
Consulting Via Partners:
Yes
