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EUDAMED registration 08806102610985No

Sterile Single-Use Syringes with filter needles

Korea Vaccine co., Ltd.Class IEU EUDAMEDTrade name: KOVAX-FILTERNEEDLE SYRINGE
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
A02010499
Trade name
KOVAX-FILTERNEEDLE SYRINGE
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08806102610985
Basic UDI
880610260005BF
Version date
December 09, 2022
Manufacturer last update
September 05, 2022
Active status
No
Manufacturer
Manufacturer name
Korea Vaccine co., Ltd.
Country
Republic of Korea
Country type
NON_EU
Address
426 Samii-daero, Jongno-gu Seoul
Email
kkh8798@koreavaccine.com
Authorized representative
Name
Certification Experts
SRN
NL-AR-000000235
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
e.unk@certification-experts.com
Telephone
+31850073210
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SYRINGES FOR INJECTOR, SINGLE-USE - OTHER

About this record

Access comprehensive regulatory information for Sterile Single-Use Syringes with filter needles 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 08806102610985 and manufactured by Korea Vaccine co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (KOVAX-FILTERNEEDLE SYRINGE), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.