EDGE ENGINE Sub-2ms Deterministic V8 Execution • Zero Data Retention Explore API Specs →
Latency: <2ms Edge Availability: 99.99% Standard: EU MDR 2017/745 / EUDAMED V8 Pure Compute

EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI Spec

Verify Basic UDI-DI and UDI-DI data models for European EUDAMED regulatory compliance.

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

Quick Technical Summary: Verify Basic UDI-DI and UDI-DI data models for European EUDAMED regulatory compliance. Implementation conforms to FDA 21 CFR 801.20 / EU MDR 2017/745.

Execution SLA
<2ms Edge (Cloudflare V8)
Governing Norm
EU MDR 2017/745 / EUDAMED
Throughput Limit
512 KB / Payload
Data Privacy
100% In-Memory (Zero Store)

Specification & Structural Breakdown

EU MDR introduces the Basic UDI-DI as the main key in EUDAMED representing device models sharing intended purpose and risk class.

IdentifierLevelFormatUsage
Basic UDI-DIModel / FamilyGS1 GSRC / HIBCC / ICCBBA codeEU Certificates & Declarations of Conformity
UDI-DIPackaged ItemGTIN-14 / HIBC PrimaryTrade item packaging and barcode
Interactive Edge Validator

Test EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI 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.

Launch Workbench →

Parsed JSON Response Model

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

HTTP 200 JSON Payload
{
  "eudamedValidation": "PASS",
  "basicUdiDi": "008848380DEVICEFAM88",
  "udiDi": "00884838012345",
  "mdrCompliant": true
}

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 is the difference between Basic UDI-DI and UDI-DI in Europe?

The Basic UDI-DI is purely an administrative regulatory key on certificates, whereas UDI-DI is printed directly on the device package barcode.

Related Medical Device UDI Barcode & AIDC Engine Formats

Explore sibling specifications and standards in the same developer cluster: