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dBest H. Pylori Saliva (HPS) Test Kit - EUDAMED Registration 06941571802317

Access comprehensive regulatory information for dBest H. Pylori Saliva (HPS) Test Kit in the European Union medical device market through Pure Global AI's free database. This IVD devices for self-testing device is registered with EU EUDAMED under Primary DI 06941571802317 and manufactured by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. in China.

This page provides complete registration details including 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.

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EUDAMED Official Data
IVD devices for self-testing
06941571802317
No
dBest H. Pylori Saliva (HPS) Test Kit
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

H. PYLORI - RT & POC

Device Classification
Risk Class
IVD devices for self-testing
CND Nomenclatures Code
W0105090102
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06941571802317
Basic UDI
B-06941571802317
Version Date
June 01, 2022
Manufacturer Last Update
February 21, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
K4-2 Science Technology Garden, Economic Development Zone Tongxiang, Zhejiang
Email
cxd@ameritek.org
Authorized Representative
SRN
NL-AR-000000111
Country
Netherlands
Address
13 Esdoornlaan Maarn
Email
office@cepartner4u.com
Telephone
+31343442524
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Germany
Market Available
Czechia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Iceland:None~None, Italy:None~None, Latvia:None~None, Lithuania:None~None, Netherlands:None~None, Poland:None~None, Romania:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
Yes