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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

ME01 — Class I MDR by MEdisain Oy

MD Atlas
MEdisain Oy

EUDAMED last updated this device on Jan 24, 2022

ME01

6429810798ME018A

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEdisain Oy
UDI-DI code: 06429810798008
Reference / catalog number: ME01

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Manufacturer information

Organization name: MEdisain Oy
SRN: FI-MF-000012422
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: 06429810798008
Basic UDI-DI: 6429810798ME018A
Reference / catalog number: ME01
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 hoitoon, sekä hoitoon jolloin kättä tai olkapäätä ei tule liikuttaa. Tuotetta käytetään lääkärin määräysten mukaisesti. Tuote otetaan aina käyttöön ammattihenkilön ohjauksessa. Tuote on potilaskohtainen ja kertakäyttöinen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M030501IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE

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.