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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

4F013A24560M — Class I MDR by Image Wear Oy

MD Atlas
Image Wear Oy

EUDAMED last updated this device on Dec 21, 2021

4F013A24560M

64180104F013A24JU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Image Wear Oy
UDI-DI code: 06418010344696
Reference / catalog number: 4F013A24560M

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Manufacturer information

Organization name: Image Wear Oy
SRN: FI-MF-000018231
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06418010344696
Basic UDI-DI: 64180104F013A24JU
Reference / catalog number: 4F013A24560M
Issuing entity: GS1

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: Surgical gowns, used as medical devices for clinical staff.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020402REINFORCED SURGICAL GOWNS

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.