Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Opal Trial Implant — 9 UDI-DI variants, MDR (Synthes GmbH)

MD Atlas
Synthes GmbH

Data from EUDAMED, last updated May 23, 2026

Opal Trial Implant

7611819a00519JW

9 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Synthes GmbH

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 7611819a00519JW
Device name: Opal Trial Implant
Device model: Spine Trial Implants for Opal
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jul 11, 2025

Manufacturer & authorised representative

Manufacturer

Name: Synthes GmbH
SRN: CH-MF-000013345
Country: Switzerland
Email: EUDAMED_Enquiries@its.jnj.com
Phone: +41 (0) 61 965 61 11

Authorised representative

Name: DePuy Ireland UC
SRN: IE-AR-000009328
Country: Ireland
Phone: +353 (0)21 4914000

Variants by status

UDI-DI variants

9 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01JZX4VRFENHW6D1FFB9S6BY7W

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

03.803.01307611819941076
03.803.01007611819941045
03.803.01107611819941052
03.803.01707611819941090
03.803.00807611819941021
03.803.01507611819941083
03.803.01207611819941069
03.803.00907611819941038
03.803.00707611819941014