Medical Device UDI Barcode & AIDC Engine
Decode medical device Unique Device Identifiers (UDI) across all 3 FDA/EU accredited issuing agencies: GS1, HIBCC, and ICCBBA.
⚡ Live Pure-Compute Playground
Test deterministic edge parsing with sub-2ms execution across 330+ Cloudflare V8 edge locations. Zero persistent storage, zero cold-starts, pure function $f(x)=y$.
Key Capabilities & Performance Architecture
- ✓ Universal support for GS1-128 / GS1 DataMatrix, HIBCC (Health Industry Bar Code), and ICCBBA ISBT 128
- ✓ Automated Device Identifier (DI) and Production Identifier (PI) separation (Lot, Serial, Expiration, Manufacturing Date)
- ✓ HIBCC Modulo-43 checksum calculation and verification
- ✓ FDA GUDID and European Union EUDAMED submission readiness check
- ✓ Deterministic pure compute execution on Cloudflare Workers (<3ms latency)
- ✓ Public sandbox endpoints process synthetic and test data only — live PHI is not accepted anywhere on the platform until the HIPAA compliance program (BAA execution, audit) is formally announced.
Issuing Agency UDI Specifications (8 Specifications)
Explore full structural breakdowns, checksum logic, and field schemas for every supported format.
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 Specification →HIBCC Medical Device Barcode Decoder & Modulo-43 Checksum Spec
Parse primary and secondary HIBCC medical barcodes with Modulo-43 check character validation.
View Specification →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 Specification →FDA Global UDI Database (GUDID) Submission & Compliance Spec
Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA.
View Specification →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 Specification →FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification
Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications.
View Specification →Medical Device Barcode Decoder — 2D DataMatrix, GS1-128 & Hospital Scanners
Decode 2D DataMatrix and linear GS1-128 barcodes scanned at hospital bedsides and surgical supply rooms into structured JSON.
View Specification →EU EUDAMED Basic UDI-DI & UDI-DI Validation Architecture
Validate European Union MDR & IVDR Basic UDI-DI keys and packaging UDI-DI hierarchies for EUDAMED regulatory submission.
View Specification →API Endpoints & Request Signatures
| Method | Path | Description |
|---|---|---|
POST |
/api/v1/udi/decode |
Decode raw UDI barcode string and extract DI/PI elements |
POST |
/api/v1/udi/validate |
Validate issuing agency syntax and check digits |
Sample Response JSON Payload
All endpoints deliver strongly-typed envelopes with deterministic parsing and performance metrics.
{
"success": true,
"data": {
"issuingAgency": "GS1",
"deviceIdentifier": "00884838012345",
"productionIdentifier": {
"expirationDate": "2026-08-31",
"lotNumber": "LOT7788",
"serialNumber": "SN991823"
},
"gudidCompatible": true,
"eudamedCompatible": true
},
"meta": {
"latency_ms": 1.45,
"version": "1.0.0"
}
}Multi-Language Integration Code
Copy and paste ready-to-run snippets with your direct API credentials:
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
The US FDA and European Commission accredit three issuing agencies: GS1, HIBCC (Health Industry Business Communications Council), and ICCBBA (International Council for Commonality in Blood Banking Automation).
UDI-DI (Device Identifier) is the mandatory fixed identifier for the device model/labeler. UDI-PI (Production Identifier) encodes dynamic manufacturing attributes (lot, expiration date, serial number, donation identification number).