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.

TomoFix High Tibia Plate — 12 UDI-DI variants, MDR (Synthes GmbH)

MD Atlas
Synthes GmbH

Data from EUDAMED, last updated May 23, 2026

TomoFix High Tibia Plate

7611819a00470JR

12 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
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

Implantable

Identity & classification

Basic UDI-DI: 7611819a00470JR
Device name: TomoFix High Tibia Plate
Device model: TomoFix High Tibia Plate
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Aug 15, 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

12 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

basicUdiUlid01K2Q81TKN9ATTTX6TDHF295KK

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

440.83707612334080226
440.837S07612334080240
440.83807612334080233
440.831S07611819941908
440.83407611819254442
440.853S07611819245785
440.84307611819282841
440.85307611819282858
440.83107611819941892
440.834S07611819245761
440.838S07612334080257
440.843S07611819245778