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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

AM30391 — Class I MDR by diawin Deutschland GmbH

MD Atlas
diawin Deutschland GmbH

EUDAMED last updated this device on Jul 15, 2024

AM30391

858602288AM3039192

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: diawin Deutschland GmbH
UDI-DI code: 08586022882876
Reference / catalog number: AM30391

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Manufacturer information

Organization name: diawin Deutschland GmbH
SRN: DE-MF-000040108
Manufacturer status: Active

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AF17361B-04260502820995On the market DI11433B-08586022884870On the market AM30403858602288AM304038GOn the market AM18472B-04260502825037On the market AM18443B-04260502823521On the market

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08586022882876
Basic UDI-DI: 858602288AM3039192
Reference / catalog number: AM30391
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

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

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.