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FDA 21 CFR 801.20 / EU MDR 2017/745 <2ms Edge Edge Compute

FDA Global UDI Database (GUDID) Submission & Compliance Spec

Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA. This specification documents the exact field layout, checksum rules, and validation behavior so your integration matches FDA 21 CFR 801.20 / EU MDR 2017/745 without reading the source standard.

Latency: <2ms Edge Availability: 99.99% Standard: FDA GUDID HL7 SPL In-Memory Execution
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{
  "status": "Click RUN VALIDATION to execute on the Cloudflare edge..."
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Official Standard & Validation Protocol Authority: FDA AccessGUDID Database & IMDRF ↗

Quick Summary: Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA. Validates strictly against FDA 21 CFR 801.20 / EU MDR 2017/745 with sub-5ms in-memory response times.

Latency
<2ms Edge
Standard
FDA GUDID HL7 SPL
Version
Max Payload
512 KB
Privacy
In-Memory (0 bytes stored)

Specification & Structural Breakdown

Technical Summary: Validates strictly against FDA 21 CFR 801.20 / EU MDR 2017/745. Payloads are parsed in memory and return clean, typed JSON in milliseconds with zero data logged.

GUDID serves as the reference catalog for every medical device with an assigned UDI sold in the United States.

FieldRequirementDescription
Primary DI NumberMandatoryGTIN-14, HIBC, or ISBT 128 DI
Brand Name / Device DescriptionMandatoryCommercial product name
FDA Listing Number / Premarket SubmissionConditional510(k), PMA, or De Novo number

Parsed JSON Response Model

The edge microservice transforms input payloads into strongly-typed hierarchical JSON envelopes with sub-5ms latency:

HTTP 200 JSON Response Envelope
{
  "gudidValidation": "PASS",
  "primaryDi": "00884838012345",
  "deviceDescription": "Titanium Orthopedic Bone Screw 4.5mm"
}

Copy-Paste Integration Code (6 Languages)

Integrate FDA Global UDI Database (GUDID) Submission & Compliance Spec directly into your production application with native, zero-dependency code snippets in cURL, Node.js, Python, Go, C#, and a ready-to-paste Claude prompt. Get a free API key → (no credit card required):

curl --request POST \
  --url "https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode" \
  --header "Content-Type: application/json" \
  --header "x-api-key: YOUR_API_KEY" \
  --data '{
  "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}'
const response = await fetch("https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode", {
  method: "POST",
  headers: {
    "Content-Type": "application/json",
    "x-api-key": process.env.API_KEY || "YOUR_API_KEY"
  },
  body: JSON.stringify({
  "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
})
});

const data = await response.json();
console.log(data);
import requests
import json

url = "https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode"
headers = {
    "Content-Type": "application/json",
    "x-api-key": "YOUR_API_KEY"
}
payload = {
    "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}

response = requests.post(url, json=payload, headers=headers)
print(response.json())
package main

import (
	"bytes"
	"fmt"
	"io"
	"net/http"
	"os"
)

func main() {
	url := "https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode"
	payload := []byte(`{"udi":"(01)00884838012345(17)260831(10)LOT7788(21)SN991823"}`)

	req, _ := http.NewRequest("POST", url, bytes.NewBuffer(payload))
	req.Header.Add("Content-Type", "application/json")
	req.Header.Add("x-api-key", os.Getenv("API_KEY"))

	res, err := http.DefaultClient.Do(req)
	if err != nil {
		panic(err)
	}
	defer res.Body.Close()
	body, _ := io.ReadAll(res.Body)
	fmt.Println(string(body))
}
using System;
using System.Net.Http;
using System.Text;
using System.Threading.Tasks;

class Program
{
    static async Task Main()
    {
        using var client = new HttpClient();
        client.DefaultRequestHeaders.Add("x-api-key", Environment.GetEnvironmentVariable("API_KEY") ?? "YOUR_API_KEY");

        var json = @"{""udi"":""(01)00884838012345(17)260831(10)LOT7788(21)SN991823""}";
        var payload = new StringContent(json, Encoding.UTF8, "application/json");

        var response = await client.PostAsync("https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode", payload);
        var content = await response.Content.ReadAsStringAsync();
        Console.WriteLine(content);
    }
}
Integrate the StanzaAPI udi-decoder micro-API.

Endpoint: POST https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode
Auth header: x-api-key: YOUR_API_KEY
Content-Type: application/json
Request body:
{
  "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}

Rules:
- Send the request with a 2-second timeout.
- Parse the standard envelope { success, data, meta: { latency_ms, version } }.
- On failure, read { success: false, error, code } and branch on the code.
- Do not retry 4xx responses; surface the error code to the caller.
- Treat invalid-but-well-formed payloads as HTTP 200 with data.valid === false.

Frequently Asked Questions & Technical Notes

What premaket submissions require GUDID entry?

All Class I, Class II, and Class III medical devices marketed in the US require GUDID registration.

Related Medical Device UDI Barcode & AIDC Engine Formats

Explore sibling specifications and standards in the same developer cluster:

Complementary Enterprise APIs

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All Medical Device UDI Barcode & AIDC Engine Formats & Specifications (8) Directory Index ↓
GS1 UDI Barcode Format & AI Parser Guide (GS1-128 & DataMatrix) HIBCC Medical Device Barcode Decoder & Modulo-43 Checksum Spec ICCBBA ISBT 128 Medical Device & Cellular Therapy UDI Spec FDA Global UDI Database (GUDID) Submission & Compliance Spec EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI Spec FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification Medical Device Barcode Decoder — 2D DataMatrix, GS1-128 & Hospital Scanners EU EUDAMED Basic UDI-DI & UDI-DI Validation Architecture