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CRF-GBU-B - EUDAMED Registration 10811746030698

Access comprehensive regulatory information for CRF-GBU-B in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 10811746030698 and manufactured by Cambridge Interventional LLC in United States.

This page provides complete registration details including trade name (GuideBlockCRF-U), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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 IIb
10811746030698
Yes
CRF-GBU-B
Trade Name: GuideBlockCRF-U
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Device Description (EMDN)

ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z12010902
Trade Name
GuideBlockCRF-U
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
10811746030698
Basic UDI
B-10811746030698
Version Date
July 27, 2022
Manufacturer Last Update
March 23, 2022
Active Status
Yes
Manufacturer
Country
United States
Country Type
NON_EU
Address
78 Cambridge Street Burlington
Email
info@cambint.com
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Italy
Market Available
Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None, Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No