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Organization name
UDI-DI code
Reference / catalog number

60096 — Class I MDR by Werkmeister GmbH + Co. KG

MD Atlas
Werkmeister GmbH + Co. KG

EUDAMED last updated this device on Sep 9, 2025

60096

4048486310301Y6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Werkmeister GmbH + Co. KG
UDI-DI code: 04048486228941
Reference / catalog number: 60096

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Manufacturer information

Organization name: Werkmeister GmbH + Co. KG
SRN: DE-MF-000005120
Manufacturer status: Active

Related devices

3076/STÜCK4048486110301XCOn the market 3075/STÜCK4048486110301XCOn the market 160140408RE40484862646012WOn the market 160144442RE40484862646012WOn the market 160144442LI40484862646012WOn the market

Critical warnings

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

CW999
Großflächige Wunden, insbes. plantar. Wunden sind vor der Verwendung mit ausreichenden Verbänden zu versehen da das Produkt nicht für den direkten Kontakt mit Wunden ausgelegt ist. Unverträglichkeiten gegen im Produkt verarbeitete Materialien.

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: 04048486228941
Basic UDI-DI: 4048486310301Y6
Reference / catalog number: 60096
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: Wewa® Ped Diabetikerschuh Größe 43 HMV: 31.03.03.4138
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.