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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Perfix Plaster of Paris Bandages — 3 UDI-DI variants, MDR

MD Atlas
Sopharma AD

Data from EUDAMED, last updated May 23, 2026

Perfix Plaster of Paris Bandages

3800010632002698

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Sopharma AD

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Device characteristics

No device characteristics flagged

Clinical investigations

Investigation number: WD-QM-001-CER
Registered: No
Countries: China

Investigation number: Cytotoxicity assay № SDWH-PROTOCOL–M201502244-1 – Soochow University
Registered: No
Countries: China

Investigation number: Intracutaneous irritation test № SDWH-PROTOCOL–M201502244-3 – Soochow University
Registered: No
Countries: China

Investigation number: Closed path sensitization study № SDWH-PROTOCOL – M201502244-2 – Soochow University
Registered: No
Countries: China

Identity & classification

Basic UDI-DI: 3800010632002698
Device name: Perfix Plaster of Paris Bandages
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: May 27, 2022

Manufacturer & authorised representative

Manufacturer

Name: Sopharma AD
SRN: BG-MF-000019983
Country: Bulgaria
Email: mail@sopharma.bg
Phone: +35980020222

Variants by status

UDI-DI variants

3 UDI-DI variants

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basicUdiUlid01G42NENVMZ7D8T5BBMR4P55Q2

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Perfix Plaster of Paris Bandages03800728493804
Perfix Plaster of Paris Bandages03800728493828
Perfix Plaster of Paris Bandages03800728493811