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Physiolab S1 Unit - EUDAMED Registration 05060538870570

Access comprehensive regulatory information for Physiolab S1 Unit 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 05060538870570 and manufactured by Physiolab Technologies Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including 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
05060538870570
No
Physiolab S1 Unit
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

CRYOTHERAPY AND THERMOTHERAPY DEVICES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
M9001
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060538870570
Basic UDI
506053887S1R4
Version Date
July 02, 2024
Manufacturer Last Update
July 23, 2021
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Unit 2 Centurion Court Milton Keynes
Email
quality@physiolab.com
Authorized Representative
SRN
IE-AR-000002496
Country
Ireland
Address
Block B, The Crescent Building, Dublin 9
Email
EU-Rep@medicaldevicemanagement.com
Telephone
+353 (0) 1893 4143
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
Ireland
Market Available
Ireland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No