Pure Global

REVERSER - EUDAMED Registration 08698980480831

Access comprehensive regulatory information for REVERSER in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08698980480831 and manufactured by SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ in Türkiye.

This page provides complete registration details including trade name (S.C.A), manufacturer information, competent authority (Turkish Medicine and Medical Devices Agency), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
08698980480831
No
REVERSER
Trade Name: S.C.A
Pure Global
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Device Description (EMDN)

BONE RONGEURS, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L091302
Trade Name
S.C.A
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
08698980480831
Basic UDI
868086255S.C.A3545TQ
Version Date
May 03, 2024
Manufacturer Last Update
January 06, 2022
Active Status
No
Manufacturer
Country
Türkiye
Country Type
EU_EXTENDED
Address
47 / 49 Kirazlık Mahallesi Sahil Caddesi Tekkeköy SAMSUN
Email
info@sca.com.tr
Regulatory Information
Competent Authority
Turkish Medicine and Medical Devices Agency
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Türkiye
Market Available
Austria:2015-12-31~None, Belgium:2015-12-31~None, Bulgaria:2015-12-31~None, Croatia:2015-12-31~None, Cyprus:2015-12-31~None, Czechia:2015-12-31~None, Denmark:2015-12-31~None, Estonia:2015-12-31~None, Finland:2015-12-31~None, France:2015-12-31~None, Germany:2015-12-31~None, Greece:2015-12-31~None, Hungary:2015-12-31~None, Iceland:2015-12-31~None, Ireland:2015-12-31~None, Italy:2015-12-31~None, Latvia:2015-12-31~None, Liechtenstein:2015-12-31~None, Lithuania:2015-12-31~None, Luxembourg:2015-12-31~None, Malta:2015-12-31~None, Netherlands:2015-12-31~None, Norway:2015-12-31~None, Poland:2015-12-31~None, Portugal:2015-12-31~None, Romania:2015-12-31~None, Slovakia:2015-12-31~None, Slovenia:2015-12-31~None, Spain:2015-12-31~None, Sweden:2015-12-31~None, Türkiye:2015-12-31~None, United Kingdom (Northern Ireland only):2015-12-31~None
Device Characteristics
Human Tissues
No
Animal Tissues
No