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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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Opharm medical mask IIR SANI-DM-11 — 2 UDI-DI variants, MDR

MD Atlas
Opharm S.A.

Data from EUDAMED, last updated May 30, 2026

Opharm medical mask IIR SANI-DM-11

590430208SANIDM11PY

2 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: Opharm S.A.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 590430208SANIDM11PY
Device name: Opharm medical mask IIR SANI-DM-11
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jun 3, 2022

Manufacturer & authorised representative

Manufacturer

Name: Opharm S.A.
SRN: PL-MF-000011509
Country: Poland
Email: info@opharm.pl
Phone: +48534400388

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G4MSDK8EFHG8AAZ3HZHFB47B

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

SANI-DM-1105904302081987
SANI-DM-1105904302081864