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

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BME ELITE and BME ELITE Y Drill Guide… — 2 UDI-DI variants, MDR

MD Atlas
Synthes GmbH

Data from EUDAMED, last updated May 23, 2026

BME ELITE and BME ELITE Y Drill Guide Kit

7611819a00638K7

2 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

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 7611819a00638K7
Device name: BME ELITE and BME ELITE Y Drill Guide Kit
Device model: BME ELITE and BME ELITE Y Drill Guide Kit
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jul 30, 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

2 UDI-DI variants

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Applied filters

basicUdiUlid01K1EDZPM1TT56KVJRSJCNFZ39

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

EL-DTY00810633021972
EL-DTS00810633021965