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Sharay Specific IgE (19 Allergens) (CLIA) - EUDAMED Registration 06975070766016

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 06975070766016 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 Dรผsseldorf 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.

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EUDAMED Official Data
IVD General
06975070766016
No
Sharay Specific IgE (19 Allergens) (CLIA)
Trade Name: Sharay Specific IgE (19 Allergens) (CLIA)
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Device Description (EMDN)

IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT

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
06975070766016
Basic UDI
B-06975070766016
Version Date
August 07, 2024
Manufacturer Last Update
April 25, 2023
Active Status
No
Manufacturer
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
SRN
DE-AR-000010869
Country
Germany
Address
47 Harffstr. Dรผsseldorf
Email
de.rep@sungoglobal.com
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf 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