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Specimen Cup - EUDAMED Registration 05051223035329

Access comprehensive regulatory information for Specimen Cup 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 05051223035329 and manufactured by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Medium Opaque Specimen Cup ), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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
05051223035329
No
Specimen Cup
Trade Name: Medium Opaque Specimen Cup
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Device Description (EMDN)

DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A99
Trade Name
Medium Opaque Specimen Cup
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05051223035329
Basic UDI
B-05051223035329
Version Date
February 20, 2024
Manufacturer Last Update
January 10, 2024
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
2 Chestnut House Shenley
Email
glen.hillsley@purplesurgical.com
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Spain
Market Available
France:2024-02-20~None, Germany:2024-02-20~None, Italy:2024-02-20~None, Portugal:2024-02-20~None, Spain:2024-02-20~None
Device Characteristics
Human Tissues
No
Animal Tissues
No