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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

4.0191 — Class I MDR by Thanner GmbH

MD Atlas
Thanner GmbH

EUDAMED last updated this device on May 14, 2024

4.0191

42518308DiabeticusschuhZP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Thanner GmbH
UDI-DI code: 04251830812066
Reference / catalog number: 4.0191

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Manufacturer information

Organization name: Thanner GmbH
SRN: DE-MF-000032767
Manufacturer status: Active

Related devices

4.011342518308DiabeticusschuhZPOn the market 4.008842518308DiabeticusschuhZPOn the market 4.012642518308DiabeticusschuhZPOn the market 4.513442518308DiabeticusschuhZPOn the market 4.713542518308DiabeticusschuhZPOn 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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04251830812066
Basic UDI-DI: 42518308DiabeticusschuhZP
Reference / catalog number: 4.0191
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: https://www.thanner-gmbh.com/gebrauchsanweisung/dia.php
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