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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

Clean air suit with long sleeves — Class I MDR

MD Atlas
Suirsafe Technologies Ltd.

EUDAMED last updated this device on Jan 25, 2022

Clean air suit with long sleeves

PP12054SMCS58415.43

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suirsafe Technologies Ltd.
UDI-DI code: 111792000600
Reference / catalog number: SMCS2

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Manufacturer information

Organization name: Suirsafe Technologies Ltd.
SRN: IE-MF-000004594
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: Clean air suit with long sleeves
UDI-DI code: 111792000600
Basic UDI-DI: PP12054SMCS58415.43
Reference / catalog number: SMCS2
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: Disposable Clean air suit made from soft lightweight polypropylene. The material is antistatic, very breathable and pliable. The garment has a low lint elastic collar on the neck, low lint elastic cuffs at the arms, waist and ankle to prevent contamination of an operating room with bacteria and skin scales falling from human skin. Preventing the contamination of an operating room is vital for prevention of post surgery infections in the patients. The set includes a long-sleeved shirt with pockets and pants.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0299PROTECTION DRAPES AND GARMENTS - OTHER

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.