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Gastric Band Positioning Device 455mm - EUDAMED Registration 05051986011288

Access comprehensive regulatory information for Gastric Band Positioning Device 455mm 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 05051986011288 and manufactured by Surgical Innovations Ltd. in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Gastric Band Positioning Device 455mm), 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
05051986011288
No
Gastric Band Positioning Device 455mm
Trade Name: Gastric Band Positioning Device 455mm
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Device Description (EMDN)

MINIMALLY INVASIVE SURGERY DISSECTORS, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
K01020101
Trade Name
Gastric Band Positioning Device 455mm
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05051986011288
Basic UDI
B-05051986011288
Version Date
July 13, 2023
Manufacturer Last Update
August 25, 2021
Active Status
No
Manufacturer
Manufacturer Name
Surgical Innovations Ltd.
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
6 Clayton Wood House, Clayton Wood Bank Leeds
Email
si@surginno.co.uk
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Ireland
Market Available
Austria:None~None, Belgium:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Finland:None~None, France:None~None, Germany:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Norway:None~None, Poland:None~None, Romania:None~None, Slovakia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No