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Ultra Stop Bur - EUDAMED Registration 50609129532192

Access comprehensive regulatory information for Ultra Stop Bur in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 50609129532192 and manufactured by OsteoCare Implant System Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Ultra Stop Bur), 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 IIa
50609129532192
No
Ultra Stop Bur
Trade Name: Ultra Stop Bur
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Device Description (EMDN)

ODONTOSTOMATOLOGY BURS, REUSABLE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
L159007
Trade Name
Ultra Stop Bur
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
50609129532192
Basic UDI
B-50609129532192
Version Date
September 22, 2022
Manufacturer Last Update
November 19, 2021
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
1A High Street Epsom
Email
info@osteocare.uk.com
Authorized Representative
SRN
IE-AR-000009841
Country
Ireland
Address
13 South Terrace Cork
Email
Info@osteocare.uk.com
Telephone
+ 353 212063393
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Ireland
Market Available
Greece:None~None, Ireland:None~None, Spain:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No