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.

Craniofacial bone distractor system… — 17 UDI-DI variants, MDR

MD Atlas
Synthes GmbH

Data from EUDAMED, last updated May 23, 2026

Craniofacial bone distractor system component multiple use

7611819a00016HX

17 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
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: 7611819a00016HX
Device name: Craniofacial bone distractor system component multiple use
Device model: Craniofacial bone distractor system component multiple use
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
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

17 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

basicUdiUlid01JZX7T8F5H5FB58DY5ES4QA27

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

314.40807611819809239
314.40407611819743687
387.42507611819737396
314.40707611819809222
03.315.00307611819947702
314.40607611819809215
03.500.01607611819496118
03.307.01007611819809109
387.42307611819713321
03.315.00507611819947825
03.315.00407611819947818
03.500.01507611819492509
387.42207611819713314
03.315.00107611819947696
394.99007611819700260
387.42407611819713338
395.10107611819743694