Pure Global AI
EUDAMED registration 06941571840302No

Fecal Occult Blood Rapid Test

Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.IVD devices for self-testingEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD devices for self-testing
CND nomenclatures code
W0103010601
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06941571840302
Basic UDI
B-06941571840302
Version date
May 20, 2022
Manufacturer last update
February 21, 2022
Active status
No
Manufacturer
Manufacturer name
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Country
China
Country type
NON_EU
Address
K4-2 Science Technology Garden, Economic Development Zone Tongxiang, Zhejiang
Email
cxd@ameritek.org
Authorized representative
Name
CEpartner4U
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
Czech Republic: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
Device description (EMDN)

HAEMOGLOBIN (HB)

About this record

Access comprehensive regulatory information for Fecal Occult Blood Rapid Test 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 06941571840302 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.