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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 SMIG1 — Class I MDR by Suirsafe Technologies…

MD Atlas
Suirsafe Technologies Ltd.

EUDAMED last updated this device on Nov 8, 2021

Isolation gown SMIG1

PP12054SMIG35492.71

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suirsafe Technologies Ltd.
UDI-DI code: 111785880432
Reference / catalog number: SMIG1

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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 SMIG1
UDI-DI code: 111785880432
Basic UDI-DI: PP12054SMIG35492.71
Reference / catalog number: SMIG1
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 30 gsm polypropylene. 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.