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Patch Perfect: Ultra-Thin - EUDAMED Registration 05065006133058

Access comprehensive regulatory information for Patch Perfect: Ultra-Thin in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 05065006133058 and manufactured by One Drop Group Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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 I
05065006133058
No
Patch Perfect: Ultra-Thin
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

HYDROCOLLOID DRESSINGS, NON-COMBINED

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M04040301
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05065006133058
Basic UDI
5065006133PP01R4
Version Date
June 17, 2024
Manufacturer Last Update
June 12, 2024
Active Status
No
Manufacturer
Manufacturer Name
One Drop Group Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
5 Lee Court Goole
Email
alex.harrison@onedropgroup.co.uk
Authorized Representative
SRN
DK-AR-000039264
Country
Denmark
Address
4 Suomisvej Frederiksberg C
Email
info@sigmatechnordic.com
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No