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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

Isolation gown SMIG2 — Class I MDR by Suirsafe Technologies…

MD Atlas
Suirsafe Technologies Ltd.

EUDAMED last updated this device on Nov 8, 2021

Isolation gown SMIG2

PP12054SMIG35492.71

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suirsafe Technologies Ltd.
UDI-DI code: 111785883351
Reference / catalog number: SMIG2

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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: Isolation gown SMIG2
UDI-DI code: 111785883351
Basic UDI-DI: PP12054SMIG35492.71
Reference / catalog number: SMIG2
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: 10
Additional product description: Isolation gown made from 25 gsm polypropylene and 15 gsm polyethylene. The gown closes with ties at the back and has elastic textile cuffs at the wrists. It is available in L and XL size in blue, green and yellow or a customised colour.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0205NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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.