GUDIDData
Bulk Audit Tool API Access
gudid Primary ID: MED610 1Kg

MED610 (UDI MED610 1Kg)

Manufactured by STRATASYS LTD

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MED610 - Primary ID MED610 1Kg

Device Regulatory Overview

The MED610 (Model/Catalog Number: MED610 1Kg) is a medical device manufactured by STRATASYS LTD. This product is indexed under FDA Product Code / Category Classification QJJ within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2091-2025 View Full Alert →

TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2094-2025 View Full Alert →

TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2090-2025 View Full Alert →

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
MED610 1Kg
Product Code / EMDN
QJJ
Device Name
MED610 is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays.MED610 is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose.MED610 is not intended for long term use (up to 24 hours only) within the oral cavity.
Database Sync Date
2026-08-09 09:18:16

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of MED610?

The registered manufacturer of record for MED610 is STRATASYS LTD.

What is the Primary UDI-DI identifier for MED610?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MED610 1Kg.

What classification code is assigned to this device?

This device is registered under product classification code QJJ.

Similar Classification Devices (QJJ)

Other Devices by STRATASYS LTD

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint