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Dengue NS1 Rapid Test - EUDAMED Registration 06936983172318

Access comprehensive regulatory information for Dengue NS1 Rapid Test in the European Union medical device market through Pure Global AI's free database. This Class C device is registered with EU EUDAMED under Primary DI 06936983172318 and manufactured by Hangzhou Alltest Biotech.Co.,Ltd. in China.

This page provides complete registration details including trade name (Dengue NS1 Rapid Test (AchieveDx Brand)), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Mรผnster), 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
Class C
06936983172318
No
Dengue NS1 Rapid Test
Trade Name: Dengue NS1 Rapid Test (AchieveDx Brand)
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Device Description (EMDN)

DENGUE - RT & POC

Device Classification
Risk Class
Class C
CND Nomenclatures Code
W0105099007
Trade Name
Dengue NS1 Rapid Test (AchieveDx Brand)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06936983172318
Basic UDI
6970277510001AXE
Version Date
December 19, 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 Mรผnster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Mรผnster
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Italy
Market Available
Italy:2024-05-23~2027-07-12
Device Characteristics
Human Tissues
No
Animal Tissues
Yes