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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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Organization name
UDI-DI code
Reference / catalog number

PSM01 — Class I MDR by Temra International Ltd

MD Atlas
Temra International Ltd

EUDAMED last updated this device on Aug 17, 2022

PSM01

PP11451PSM0194

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Temra International Ltd
UDI-DI code: PP11451
Reference / catalog number: PSM01

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Manufacturer information

Organization name: Temra International Ltd
SRN: MT-MF-000001253
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: PP11451
Basic UDI-DI: PP11451PSM0194
Reference / catalog number: PSM01
Issuing entity: IFA

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Protective Surgical Respirator "Easy Breathing" with extremely high particle, viral and bacterial filtration efficiency under optimized medical graded breathability; Splash resistant against blood and body fluids (Type IIR); Conforms to highest medical hygienic standards; intended for medical usage and during invasive surgical procedures; maximum face adaption and highest level of dual protection (level FFP2/IIR) for healthcare professionals and patients.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

PP11451

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

PSM02PP11451PSM0210On the market PSM03LPP11451PSM0323On the market UPSM03PP11451UPSM0360On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.