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Nasaleze PM Shield - EUDAMED Registration 05060045000071

Access comprehensive regulatory information for Nasaleze PM Shield 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 05060045000071 and manufactured by Nasaleze Limited in Isle of Man.

This page provides complete registration details including trade name (Nasaleze PM Shield ), 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 I
05060045000071
No
Nasaleze PM Shield
Trade Name: Nasaleze PM Shield
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Device Description (EMDN)

PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M9002
Trade Name
Nasaleze PM Shield
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060045000071
Basic UDI
5060045NPMS01NA
Version Date
January 27, 2022
Manufacturer Last Update
May 07, 2021
Active Status
No
Manufacturer
Manufacturer Name
Nasaleze Limited
Country
Isle of Man
Country Type
NON_EU
Address
Ballafletcher Business Park Isle of Man Douglas
Email
info@nasaleze.com
Authorized Representative
SRN
IE-AR-000000592
Country
Ireland
Address
Knockmorris Co. Tipperary
Email
prrc@acornregulatory.com
Telephone
+ 353 52 6176706
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Bulgaria
Device Characteristics
Human Tissues
No
Animal Tissues
No