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EUDAMED registration 08809891830831No

Surgical Loupe

Minam Optics Co., LtdClass IEU EUDAMEDTrade name: Surgical Loupe
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
L0316
Trade name
Surgical Loupe
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08809891830831
Basic UDI
8809891830831G9
Version date
October 18, 2024
Manufacturer last update
June 25, 2024
Active status
No
Manufacturer
Manufacturer name
Minam Optics Co., Ltd
Country
Republic of Korea
Country type
NON_EU
Address
59 Hakjeongdong-ro Daegu
Email
minam@minameye.com
Authorized representative
Name
AR Experts B.V.
SRN
NL-AR-000023989
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
info@ar-experts.eu
Telephone
+31889951333
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

HELMETS AND BINOCULAR GLASSES FOR SURGEONS

About this record

Access comprehensive regulatory information for Surgical Loupe 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 08809891830831 and manufactured by Minam Optics Co., Ltd in Republic of Korea.

This page provides complete registration details including trade name (Surgical Loupe), 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.