Pure Global AI
Authorized representative profile

Advena Limited

EU EUDAMEDMalta11924 represented devicesSRN MT-AR-000000234
VerifiedEUDAMED · official EU database
11,924
Total devices
11
Risk classes
2021
Earliest version
2025
Latest version
Regulatory footprint
Search Advena Limited across other regulatory registries
ThailandColombiaSouth KoreaCanadaEcuadorSaudi Arabia
Recent products (latest 10)
Most recently updated devices in the database
MOBILE DENTAL CART AMC-25CF
10817417021835
Class IIa
CALAMUS DUAL NO CORD
+D09931300701A0100
Class IIa
Nucleic acid Extraction/isolation Kit IVD
09343044004780
Class A
Disposable Sterile Cardiac Blanket
09332017000041
Class I
Dressings & Plasters
05029115011058
Class I
Dressings & Plasters
05029115011072
Class I
Convective Patient Warming Machine
09332017000553
Class IIb
BEEFILL 2 IN 1
+D099V0405410000000
Class IIa
Colorimeter Wave
15060970750000
Class I
Calamus Dual
+D099A130000000000
Class IIa
Risk class distribution
Breakdown by risk classification
Class I691758.0% of total
Class IIb266722.4% of total
Class IIa151812.7% of total
IVD General3603.0% of total
Class A2772.3% of total
Class C1080.9% of total
IVD Annex II List B290.2% of total
Class III230.2% of total
Class B220.2% of total
IVD Annex II List A20.0% of total
IVD devices for self-testing10.0% of total
Top manufacturers
Most common manufacturers represented by this AR
MF / SEWONMEDIX Inc.
14.5%1724 devices
Batrik Medical Manufacturing Inc.
9.1%1088 devices
Care & Independence Ltd
5.9%702 devices
Uro Technology Sdn. Bhd.
4.4%524 devices
Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
4.1%486 devices
About this profile

Explore comprehensive authorized representative profile for Advena Limited through Pure Global AI's free EU medical device database. This organization represents 11924 medical devices registered with EUDAMED across 11 risk classes based in Malta.

This page provides detailed insights including recent registrations, risk class distribution (Class I: 6917, Class IIa: 1518, Class A: 277, Class IIb: 2667, Class III: 23, ...), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.