# 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.

- **Canonical URL:** https://stanzaapi.com/tools/udi-decoder/standard/eudamed-basic-udi-di-lookup
- **Governing Standard:** FDA 21 CFR 801.20 / EU MDR 2017/745 (FDA AccessGUDID Database & IMDRF)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

## Technical Overview & Governing Rules
The European Union EUDAMED database utilizes a two-tier hierarchy: the Basic UDI-DI identifies the device model family on regulatory certificates, while the UDI-DI identifies the specific sellable packaging unit.

## Specification Matrix
| Level | Key Name | Length | Character Rules |
| --- | --- | --- | --- |
| Family / Model | Basic UDI-DI (GS1 GSRC) | Up to 29 chars | Company prefix + model identifier + 2 check characters |
| Family / Model | Basic UDI-DI (HIBCC) | Up to 29 chars | ++[LIC][Product Line][Check Characters] |
| Family / Model | Basic UDI-DI (ICCBBA) | Up to 29 chars | ==[Facility][Class][Category][Check] |
| Item Packaging | UDI-DI | 14 numeric (GS1) | Standard GTIN-14 with Modulo-10 check digit on box barcode |

## Standard JSON Response Model
```json
{
  "eudamedReadiness": "VALID",
  "basicUdiDi": "008848380DEVICEFAM88",
  "issuingAgency": "GS1",
  "deviceRiskClass": "Class IIb Active Implantable",
  "notifiedBodyConformity": "PASS",
  "udiDiMatched": "00884838012345"
}
```

## Frequently Asked Questions & Edge Cases
### Q: Is the Basic UDI-DI printed on the product barcode?
**A:** No. Under EU MDR rules, the Basic UDI-DI appears exclusively on the EU Declaration of Conformity and technical documentation. Only the packaging UDI-DI is encoded into the barcode.

### Q: How are the check characters calculated on GS1 Basic UDI-DI?
**A:** GS1 calculates two check characters using a Modulo-89 algorithm over the alphanumeric prefix.