Your device identifier has to be readable two ways.

A medical device label has to carry its unique device identifier in plain text a person can read, and again in a barcode a scanner can read. Send us your label. We send back what it should carry, and what yours is missing.

Join the early-access list
Preview: made-up example, not your data

Sample Medical Ltd.
Catheter, single use

REF  SM-2240
LOT  A7741
EXP  2028-04-30
STERILE EO

Four things go wrong, again and again

The identifier is there but only in the barcode. The production part is missing on a device that carries a lot number. The date is written in a format that means something different in another country. Or the device is reprocessed and reused, and the identifier is only on packaging that goes in the bin at first use.

Both forms, every time

Plain readable text and a machine-readable form. Both are required. One is not a substitute for the other.

Both parts of the identifier

The fixed part that names you and the model, and the production part carrying lot, serial or expiry where those apply.

Dates and direct marking

Dates in the required format. And where a device is reprocessed before each use, the mark goes on the device itself.

The rule we check against

21 CFR Part 801, subpart B, the Food and Drug Administration rules on unique device identification, read on 20 September 2026. Every line on your page names the rule it came from and the date we read it.

Exceptions exist, and we will not pretend otherwise. Not every device carries a unique device identifier. There are exceptions written into the rule at 21 CFR 801.30, 801.40(d) and 801.45(d). Where one may reach you, your page says so and asks, rather than assuming.

What we do not do

What your finished page looks like

This is a full sample result. Every name and number in it is made up.

Sample: made-up company, not your data
Plate Doc: Catheter, single use

Sample company: Sample Medical Ltd.

REF  SM-2240
LOT  A7741
EXP  2028-04-30
STERILE EO

What we checked on it

Which rules cover this labelFDA, 21 CFR PART 801 SUBPART B
Is the identifier in plain readable text?MISSING
Is it also machine-readable?ON THE LABEL
Are dates in the required format?ON THE LABEL
Is the device reprocessed and used again?NEEDS YOUR ANSWER

SAMPLE

Made-up example only. The real checklist depends on your device. Every line names the rule it came from and the date we read it.

What it costs

Your first result, one device

Send your label. We mark up what is missing.

Free
Founding price, per device model

For anyone on the early-access list before 31 December 2026.

$495
Standard price, per device model

One model, one checked page, every line sourced to the rule.

$750

Why this one costs more than the others. A device whose label does not carry its identifier is misbranded under section 502(c) of the Act. That is not a fine to budget for, it is a device that should not ship. A Food and Drug Administration warning letter dated 26 September 2025 cited a device for exactly the three things on your page: no device identifier, no identifier in plain text, and none in machine-readable form.

The founding price holds for anyone who joins the list before 31 December 2026. After that it goes to the standard price above.

Prices are in United States dollars. The paid step opens when the tool does. Nothing is charged before then, and joining the list costs nothing.

If it is not useful, do not pay. Tell us within 48 hours of getting your page and there is no charge. See the terms.