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FOB Fecal Occult Blood Rapid Test - EUDAMED Registration 06935091672024

Access comprehensive regulatory information for FOB Fecal Occult Blood Rapid Test 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 06935091672024 and manufactured by Qingdao Hightop Biotech Co., Ltd. in China.

This page provides complete registration details including trade name (FOB Fecal Occult Blood Rapid Test), 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
IVD General
06935091672024
No
FOB Fecal Occult Blood Rapid Test
Trade Name: FOB Fecal Occult Blood Rapid Test
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Device Description (EMDN)

FECAL OCCULT BLOOD - RT & POC

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0102160203
Trade Name
FOB Fecal Occult Blood Rapid Test
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06935091672024
Basic UDI
B-06935091672024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.369 Hedong Road Qingdao, Shandong
Email
registered@hightopqd.com
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
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Croatia
Device Characteristics
Human Tissues
No
Animal Tissues
No