FDA Global UDI Database (GUDID) Submission & Compliance Spec
Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA.
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.
Specification & Structural Breakdown
GUDID serves as the reference catalog for every medical device with an assigned UDI sold in the United States.
| Field | Requirement | Description |
|---|---|---|
| Primary DI Number | Mandatory | GTIN-14, HIBC, or ISBT 128 DI |
| Brand Name / Device Description | Mandatory | Commercial product name |
| FDA Listing Number / Premarket Submission | Conditional | 510(k), PMA, or De Novo number |
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.
Parsed JSON Response Model
The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:
{
"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 --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"
}'
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);
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())
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
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:
GS1 UDI Barcode Format & AI Parser Guide (GS1-128 & DataMatrix)
Parse GS1-128 linear barcodes and 2D DataMatrix medical device UDIs into structured DI/PI attributes in milliseconds.
View Format →HIBCC Medical Device Barcode Decoder & Modulo-43 Checksum Spec
Parse primary and secondary HIBCC medical barcodes with Modulo-43 check character validation.
View Format →ICCBBA ISBT 128 Medical Device & Cellular Therapy UDI Spec
Decode ICCBBA ISBT 128 medical and biologics identifiers for human cells, tissues, and cellular products.
View Format →EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI Spec
Verify Basic UDI-DI and UDI-DI data models for European EUDAMED regulatory compliance.
View Format →