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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

DI11392 — Class I MDD by diawin Deutschland GmbH

MD Atlas
diawin Deutschland GmbH

EUDAMED last updated this device on Nov 4, 2024

DI11392

B-08586022884740

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: diawin Deutschland GmbH
UDI-DI code: 08586022884740
Reference / catalog number: DI11392

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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

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 Slovakia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08586022884740
Basic UDI-DI: B-08586022884740
Reference / catalog number: DI11392
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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
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Software identification