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Organization name
UDI-DI code
Reference / catalog number

D1AA1035 — Class I MDR by Perpedes GmbH

MD Atlas
Perpedes GmbH

EUDAMED last updated this device on Feb 8, 2022

D1AA1035

4062627Y06333103080026BX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Perpedes GmbH
UDI-DI code: 04062627236077
Reference / catalog number: D1AA1035

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Manufacturer information

Organization name: Perpedes GmbH
SRN: DE-MF-000006250
Manufacturer status: Active

Critical warnings

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

CW011
• Bei einer akuten Läsion (Ulcus oder noch florider DNOAP / Charcot-Fuß) • Amputation Großzehe / Resektion MFK 1 • Kontralaterale Major-Amputation • Motorische Funktionseinschränkung / Parese eines oder beider Beine • Atrophie Hüfte/Knie/OSG oder Gelenkimplantat mit Funktionsbeeinträchtigung / Kontraktur • Extreme Adipositas (BMI > 35)• Dialysepflichtige Niereninsuffizienz • Höhergradige Gang- und Standunsicherheit • Erhebliche Visuseinschränkung (Eine Sehbehinderung ist eine meist dauerhafte massive Einschränkung der visuellen Wahrnehmungsfähigkeit)

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: 04062627236077
Basic UDI-DI: 4062627Y06333103080026BX
Reference / catalog number: D1AA1035
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: Diabetiker-Schuhe der Perpedes GmbH sind für Diabetespatienten indiziert. Die Modelle werden in drei Weiten angeboten, um Füße verschiedener Volumina genügend Raum zu geben. Die Entwicklung der Leisten basiert auf englischen halben Größen für eine exaktere Größenauswahl mit dem Ziel, eine möglichst ideale Passform für jeden Patienten zu finden. Alle Modelle bieten ausreichend Platz für die Einarbeitung einer individuell gefertigten diabetesadaptierten Fußbettung (DAF).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1 MU999
3.5 MU999

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

Related devices

This device is not currently linked to any other device.

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.