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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

Disposable hood SMDH1 — Class I MDR by Suirsafe Technologies…

MD Atlas
Suirsafe Technologies Ltd.

EUDAMED last updated this device on May 18, 2022

Disposable hood SMDH1

PP12054SMDH43315.18

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suirsafe Technologies Ltd.
UDI-DI code: 111811763690
Reference / catalog number: SMDH1

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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: Disposable hood SMDH1
UDI-DI code: 111811763690
Basic UDI-DI: PP12054SMDH43315.18
Reference / catalog number: SMDH1
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: 100
Additional product description: Disposable hood made from soft lightweight polypropylene. The material is antistatic, very breathable and pliable. Disposable hood prevents contamination of an operating room with bacteria, skin scales and hair, falling from human skin. Preventing the contamination of an operating room is vital for prevention of post surgery infections in the patients. The hood can also be used in cleanrooms. It is available in blue and white colour. The neck is elongated into a bib.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0207CAPS AND HEADWEAR (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.