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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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Temra Mask Dual PSM01 FFP2 NR IIR med… — 1 UDI-DI variant, MDR

MD Atlas
Temra International Ltd

Data from EUDAMED, last updated May 30, 2026

Temra Mask Dual PSM01 FFP2 NR IIR med Maske

PP11451PSM0194

1 UDI-DI variant

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

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

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: PP11451PSM0194
Device name: Temra Mask Dual PSM01 FFP2 NR IIR med Maske
Device model: PSM01
Issuing agency: IFA
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Aug 17, 2022

Manufacturer & authorised representative

Manufacturer

Name: Temra International Ltd
SRN: MT-MF-000001253
Country: Malta
Email: info@temra.net
Phone: +34 951623908

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01GAPNP4Y21QF5KCCNRG81HP2F

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

PSM01PP11451