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EUDAMED registration 06975070765958No

Sharay Specific IgE (19 Allergens) (CLIA)

C-Luminary Biotechnology Co., Ltd.IVD GeneralEU EUDAMEDTrade name: Sharay Specific IgE (19 Allergens) (CLIA)
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W01020202
Trade name
Sharay Specific IgE (19 Allergens) (CLIA)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06975070765958
Basic UDI
B-06975070765958
Version date
August 07, 2024
Manufacturer last update
April 25, 2023
Active status
No
Manufacturer
Manufacturer name
C-Luminary Biotechnology Co., Ltd.
Country
China
Country type
NON_EU
Address
Building #3, No. 6, Xixin Avenue, High-tech zone, Chengdu, Sichuan
Email
xianjing@c-luminary.com
Authorized representative
Name
Sungo Cert GmbH
SRN
DE-AR-000010869
Country
Germany
Address
47 Harffstr. Düsseldorf
Email
de.rep@sungoglobal.com
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
Germany
Device characteristics
Human tissues
Yes
Animal tissues
Yes
Device description (EMDN)

IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT

About this record

Access comprehensive regulatory information for Sharay Specific IgE (19 Allergens) (CLIA) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06975070765958 and manufactured by C-Luminary Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Sharay Specific IgE (19 Allergens) (CLIA)), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.