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Voltran Nasal Phototherapy System-Replaceable Tip (Single) - EUDAMED Registration D-8682408640259A5

Access comprehensive regulatory information for Voltran Nasal Phototherapy System-Replaceable Tip (Single) in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI D-8682408640259A5 and manufactured by İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş. in Türkiye.

This page provides complete registration details including trade name (VOLTRAN), 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 IIa
D-8682408640259A5
No
Voltran Nasal Phototherapy System-Replaceable Tip (Single)
Trade Name: VOLTRAN
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Device Description (EMDN)

PHOTOTHERAPY EQUIPMENT

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12040202
Trade Name
VOLTRAN
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-8682408640259A5
Basic UDI
B-8682408640259A5
Version Date
August 12, 2024
Manufacturer Last Update
February 06, 2022
Active Status
No
Manufacturer
Country
Türkiye
Country Type
EU_EXTENDED
Address
2010 ALCI OSB MAHALLESİ 06930 ANKARA
Email
esraakin@invamed.com
Regulatory Information
Competent Authority
Turkish Medicine and Medical Devices Agency
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Türkiye
Market Available
Austria:2021-05-19~2028-12-31, Belgium:2021-05-19~2028-12-31, Bulgaria:2021-05-19~2028-12-31, Croatia:2021-05-19~2028-12-31, Cyprus:2021-05-19~2028-12-31, Czechia:2021-05-19~2028-12-31, Denmark:2021-05-19~2028-12-31, Estonia:2021-05-19~2028-12-31, Finland:2021-05-19~2028-12-31, France:2021-05-19~2028-12-31, Germany:2021-05-19~2028-12-31, Greece:2021-05-19~2028-12-31, Hungary:2021-05-19~2028-12-31, Iceland:2021-05-19~2028-12-31, Ireland:2021-05-19~2028-12-31, Italy:2021-05-19~2028-12-31, Latvia:2021-05-19~2028-12-31, Liechtenstein:2021-05-19~2028-12-31, Lithuania:2021-05-19~2028-12-31, Luxembourg:2021-05-19~2028-12-31, Malta:2021-05-19~2028-12-31, Netherlands:2021-05-19~2028-12-31, Norway:2021-05-19~2028-12-31, Poland:2021-05-19~2028-12-31, Portugal:2021-05-19~2028-12-31, Romania:2021-05-19~2028-12-31, Slovakia:2021-05-19~2028-12-31, Slovenia:2021-05-19~2028-12-31, Spain:2021-05-19~2028-12-31, Sweden:2021-05-19~2028-12-31, Türkiye:2021-05-19~2028-12-31, United Kingdom (Northern Ireland only):2021-05-19~2028-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No