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Latency: <2ms Edge Availability: 99.99% Standard: FDA GUDID HL7 SPL V8 Pure Compute

FDA Global UDI Database (GUDID) Submission & Compliance Spec

Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA.

Official Regulatory Standard & Verification Protocol Authority: FDA AccessGUDID Database & IMDRF ↗

Quick Technical Summary: Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA. Implementation conforms to FDA 21 CFR 801.20 / EU MDR 2017/745.

Execution SLA
<2ms Edge (Cloudflare V8)
Governing Norm
FDA GUDID HL7 SPL
Throughput Limit
512 KB / Payload
Data Privacy
100% In-Memory (Zero Store)

Specification & Structural Breakdown

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
Interactive Edge Validator

Test FDA Global UDI Database (GUDID) Submission & Compliance Spec Live

Paste raw inputs up to 32KB and inspect deterministic parsed JSON in real-time across 330+ Cloudflare edge locations. Pure compute, zero cold-starts.

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Parsed JSON Response Model

The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:

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

Copy-Paste Integration Code

Integrate this validator directly into your application using your production API key:

cURL
curl --request POST \
  --url "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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"
}'
Node.js (Fetch)
const response = await fetch("https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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);
Python (Requests)
import requests
import json

url = "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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())
Go
package main

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

func main() {
	url := "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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))
}

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

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