FDA & EU MDR Medical Device UDI Decoder & Validator API
Sub-5ms GS1-128, HIBCC Modulo-43 & ICCBBA ISBT 128 Medical Barcode Parser
The FDA & EU MDR Medical Device UDI Decoder & Validator API delivers instant, deterministic parsing and checksum verification for global medical device identifiers under FDA 21 CFR 801.40 and EU MDR 2017/745 regulations.
Engineered for hospital supply chains, MedTech manufacturing ERPs, electronic health records (EHR), and inventory management platforms: eliminate scanning errors, verify Modulo-43 HIBCC checksums, validate GS1 GTIN check digits, and extract lot, serial, expiration, and manufacturing dates.
Validation executes entirely in pure compute across 300+ Cloudflare edge locations with sub-5ms latency, zero cold-starts, and 100% deterministic uptime.
Features
- Universal auto-detection of GS1, HIBCC, and ICCBBA medical barcode formats
- Full HIBCC Modulo-43 mathematical checksum verification and LIC labeler extraction
- GS1 Application Identifier parser (01 GTIN, 17 Expiration, 11 Manufacturing, 10 Lot, 21 Serial)
- ICCBBA ISBT 128 support for blood, cellular therapy, and human tissue medical devices
- Structured JSON response with Device Identifier (DI) and Production Identifier (PI) separation
- Zero external subrequests or database bottlenecks for reliable <5ms edge execution
Endpoints
| Method | Path | Description | Example |
|---|---|---|---|
GET | /api/v1/udi/{udi} | Auto-detect and decode any UDI string across GS1, HIBCC, and ICCBBA formats | /api/v1/udi/%2BH12345678901230Z |
POST | /api/v1/udi | Auto-detect and decode a UDI string via JSON body | /api/v1/udi |
POST | /api/v1/hibcc | Validate and decode an HIBCC barcode with Modulo-43 checksum verification | /api/v1/hibcc |
POST | /api/v1/gs1 | Validate and decode a GS1 UDI with GTIN check digit calculation | /api/v1/gs1 |
POST | /api/v1/iccbba | Parse ICCBBA ISBT 128 blood and cellular therapy medical device identifiers | /api/v1/iccbba |
GET | /health | Service health check | /health |
FAQ
What is a Unique Device Identifier (UDI)?
A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market under FDA 21 CFR 801 and EU MDR 2017/745.
Which issuing agencies does this API support?
This API supports all three FDA-accredited issuing agencies: GS1 (GS1-128, DataMatrix, Digital Link), HIBCC (Health Industry Business Communications Council with Modulo-43 check digits), and ICCBBA (ISBT 128 for human tissues and cell therapy).
Is this API pure compute or does it rely on external government databases?
This API is 100% pure compute executing at Cloudflare Workers edge nodes. It evaluates mathematical checksums and structural standards with zero external subrequests, ensuring sub-5ms latency and 100% deterministic uptime.