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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

2828513 — Class I MDR by Mekalasi Oy

MD Atlas
Mekalasi Oy

EUDAMED last updated this device on Sep 22, 2023

2828513

6430074264130UP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mekalasi Oy
UDI-DI code: 06430074264413
Reference / catalog number: 2828513

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Manufacturer information

Organization name: Mekalasi Oy
SRN: FI-MF-000003102
Manufacturer status: Active

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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.

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: 06430074264413
Basic UDI-DI: 6430074264130UP
Reference / catalog number: 2828513
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: Idocare Visel patja on tarkoitettu käytettäväksi sängyssä pehmusteena ja painehaavojen estäjänä matalan ja keskiriskin painehaavapotilaille.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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

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