UDI-DI attributes
Device identifier, production identifier, unit of use, packaging hierarchy, and all required GUDID/EUDAMED fields — all present, or the pack does not release.
The most rigorous UDI record pack a device labeler can submit.
Global Device Identification Engine assembles a documentation-complete UDI record pack — every statutory attribute, every required nomenclature mapping, the submission-ready file, the audit trail, and the change calendar — checked against the letter of FDA GUDID and EU EUDAMED rules before a regulatory specialist releases it.
Every attribute of 21 CFR 830/801 and EU MDR/IVDR60+ structured attributes, gate-checkedGMDN · EMDN · packaging hierarchy · risk classSpecialist release on every pack5-business-day SLA
Why records fail
A single missing attribute can block market access.
A device labeler's UDI record is only as strong as the submission behind it. Miss one of the 60+ required attributes, skip a required nomenclature mapping, mis-time the EUDAMED deadline, or fail to update a record after a label change — and the submission can be rejected, the device held at customs, or the company face an audit finding.
Most labelers run this by hand, from memory, across two databases with different rules. The regulations have not been read end-to-end since the last submission. That is exactly where completeness gaps hide.
Global Device Identification Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
1 of 60+
missing attributes is enough to trigger a rejection
The benchmark
Measured against the letter of the regulations — attribute by attribute.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 21 CFR 830/801 and EU MDR/IVDR. These are the provisions each pack is held to.
Labeling & direct marking
UDI carrier format, placement, and readability verified against FDA and EU requirements; direct-marking exceptions documented.
Nomenclature mapping
GMDN (FDA) and EMDN (EU) codes selected and validated against current databases; crosswalk documented.
Risk class & conformity
Device classification verified against FDA and EU rules; Notified Body certificate references included where required.
Change management
Any label, packaging, or classification change triggers a record update; version history maintained for audit.
Submission & audit trail
Submission-ready file (HL7 SPL or XML bulk upload) generated; timestamped audit trail of every attribute change.
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A human specialist signs every release. That order is never reversed.
01
Device Gap Scan
Upload labeling, packaging specs, and technical data. We return a free completeness read: which attributes and mappings you already have, and which are missing.
02
Data extraction & mapping
As your authorized clerical agent, we extract attributes from labeling, ERP, and PLM; map to GMDN and EMDN; and build the packaging hierarchy.
03
Grounded drafting
The 60+ attributes are drafted from your validated data and the regulatory rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
Attributes reconcile to source documents; nomenclature codes validated against current databases; risk class verified; any failure blocks release.
05
Specialist release
A regulatory affairs specialist reviews the exception queue and signs the release. High-risk or novel devices route to attorney review first.
06
Delivery
You receive the pack: submission-ready file, audit trail, nomenclature crosswalk, change calendar, and submission instructions — ready for the labeler to submit under its own name.
The bar we hold
Rigor you can measure.
100%
Specialist-released
No pack ships without a human signature.
5 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
2
Regulatory databases
FDA GUDID and EU EUDAMED, every applicable file.
Why Global Device Identification Engine
Built to be the most thorough option a labeler has.
Documentation-complete, by design
The deliverable is completeness itself — every regulatory attribute and mapping accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never give legal advice, classify devices, or submit records on your behalf.
Engagement
Flat fee, per released pack. No contingency, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free Device Gap Scan before you commit — see exactly what is missing.
- One flat fee per released UDI Record Completeness Pack; disclosed pass-through search fees.
- Optional fixed-fee attorney review for high-risk or novel devices.
- Optional Lifecycle Continuity Add-on for change management and re-submission, pre-dated to your product change calendar.
FAQ
Questions, answered precisely.
Is Global Device Identification Engine a law firm?
No. Global Device Identification Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for high-risk or novel devices.
Do you submit records to FDA or EUDAMED on my behalf?
No. We prepare the submission-ready file and audit trail. The labeler remains the submitter and is responsible for final submission and attestation of accuracy.
What makes a pack 'complete'?
Completeness is defined by the regulations: all 60+ attributes present, GMDN/EMDN codes validated, risk class verified, packaging hierarchy documented, and change management plan in place. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a specialist-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through search costs. No contingency and no percentage of any recovered amount or sale proceeds.
See what's missing before it costs you market access.
Start with a free Device Gap Scan. Send your labeling, packaging specs, and technical data and we'll return a completeness read against every attribute of FDA GUDID and EU EUDAMED.
Documentation-completeness service · not legal advice · the labeler submits every record.