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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

ME04 — Class I MDR by MEdisain Oy

MD Atlas
MEdisain Oy

EUDAMED last updated this device on Feb 2, 2022

ME04

6429810798ME048G

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEdisain Oy
UDI-DI code: 06429810798039
Reference / catalog number: ME04

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Manufacturer information

Organization name: MEdisain Oy
SRN: FI-MF-000012422
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW030
Risk of frostbite

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: 06429810798039
Basic UDI-DI: 6429810798ME048G
Reference / catalog number: ME04
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: Tuote on kehitetty olkapääleikkauksen jälkeiseen kylmähoitoon. Tuotteen tarkoituksena on helpottaa kylmähoidon onnistumista, koska tuote pitää kylmäpussit paikallaan kylmähoidon ajan. Tuote otetaan käyttöön ammattihenkilön ohjauksessa. Tuotetta käytettäessä noudetettava kylmägeelipussin ohjetta.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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

Related devices

Cold pack cover for a hip6429810798ME058JOn the market ME036429810798ME038EOn the market ME026429810798ME028COn the market ME016429810798ME018AOn the market

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.