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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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iSy® Single Patient Form drill — 3 UDI-DI variants, MDR (ALTATEC GmbH)

MD Atlas
ALTATEC GmbH

Data from EUDAMED, last updated May 23, 2026

iSy® Single Patient Form drill

40997970004301000000000FH

3 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: ALTATEC GmbH

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 40997970004301000000000FH
Device name: iSy® Single Patient Form drill
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Apr 1, 2026

Manufacturer & authorised representative

Manufacturer

Name: ALTATEC GmbH
SRN: DE-MF-000006230
Country: Germany
Email: raphael.brausch@altatec.de
Phone: +49-70449445-311

Variants by status

UDI-DI variants

3 UDI-DI variants

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basicUdiUlid01KN46KQRS3SPPHD64402KCZ40

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

iSy® Single patient form drill04099797021608
iSy® Single patient form drill04099797021592
iSy® Single patient form drill04099797021615