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Diversi-Foam II Hybrid Replacement Mattress & Pump - EUDAMED Registration 05056019108010

Access comprehensive regulatory information for Diversi-Foam II Hybrid Replacement Mattress & Pump 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 05056019108010 and manufactured by Ultimate Healthcare in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Diversi-Foam), 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
05056019108010
Yes
Diversi-Foam II Hybrid Replacement Mattress & Pump
Trade Name: Diversi-Foam
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Device Description (EMDN)

ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
V080701
Trade Name
Diversi-Foam
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05056019108010
Basic UDI
B-05056019108010
Version Date
July 19, 2023
Manufacturer Last Update
March 11, 2022
Active Status
Yes
Manufacturer
Manufacturer Name
Ultimate Healthcare
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Nutsey Lane Southampton
Email
sales@ultimatehealthcare.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
United Kingdom (Northern Ireland only)
Market Available
Ireland:2020-01-01~2024-05-26, United Kingdom (Northern Ireland only):2020-01-01~2024-05-26
Device Characteristics
Human Tissues
No
Animal Tissues
No