06936983123211

Dengue Combo Rapid Test Cassette

Hangzhou Alltest Biotech.Co.,Ltd.·IVD General·EU EUDAMEDNo
Device classification
Risk class
IVD General
CND nomenclatures code
W0105099007
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06936983123211
Basic UDI
B-06936983123211
Version date
December 09, 2024
Manufacturer last update
November 11, 2024
Active status
No
Manufacturer
Country
China
Country type
NON_EU
Address
#550 Yinhai Street Hangzhou
Email
info@alltests.com.cn
Authorized representative
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Münster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory information
Competent authority
DE/CA22 - Bezirksregierung Münster
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
Yes
Device description (EMDN)

DENGUE - RT & POC

About this record

Access comprehensive regulatory information for Dengue Combo Rapid Test Cassette 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 06936983123211 and manufactured by Hangzhou Alltest Biotech.Co.,Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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.