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B20 (Heated) - EUDAMED Registration 05060969430046

Access comprehensive regulatory information for B20 (Heated) in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 05060969430046 and manufactured by Bee Robotics in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (B20), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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 A
05060969430046
No
B20 (Heated)
Trade Name: B20
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Device Description (EMDN)

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0201020180
Trade Name
B20
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060969430046
Basic UDI
506096943BB20H2S
Version Date
July 25, 2023
Manufacturer Last Update
May 16, 2022
Active Status
No
Manufacturer
Manufacturer Name
Bee Robotics
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Cibyn Ind. Est Unit 32-33 Caernarfon
Email
steve@beerobotics.com
Authorized Representative
SRN
IE-AR-000004113
Country
Ireland
Address
The Black Church Dublin
Email
edwin@cslifesciences.com
Telephone
+447917134922
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Romania
Market Available
Austria:2022-12-01~None, Belgium:2022-12-01~None, Bulgaria:2022-12-01~None, Croatia:2022-12-01~None, Cyprus:2022-12-01~None, Czechia:2022-12-01~None, Denmark:2022-12-01~None, Estonia:2022-12-01~None, Finland:2022-12-01~None, France:2022-12-01~None, Germany:2022-12-01~None, Greece:2022-12-01~None, Hungary:2022-12-01~None, Iceland:2022-12-01~None, Ireland:2022-12-01~None, Italy:2022-12-01~None, Latvia:2022-12-01~None, Liechtenstein:2022-12-01~None, Lithuania:2022-12-01~None, Luxembourg:2022-12-01~None, Malta:2022-12-01~None, Netherlands:2022-12-01~None, Norway:2022-12-01~None, Poland:2022-12-01~None, Portugal:2022-12-01~None, Romania:2022-12-01~None, Slovakia:2022-12-01~None, Slovenia:2022-12-01~None, Spain:2022-12-01~None, Sweden:2022-12-01~None, Turkey:2022-12-01~None, United Kingdom (Northern Ireland only):2022-12-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No