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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

5109 — Class I MDR by AET Australasian…

MD Atlas
AET Australasian European Trading GmbH

EUDAMED last updated this device on Apr 17, 2024

5109

42502394TSM110E4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AET Australasian European Trading GmbH
UDI-DI code: 04250239440863
Reference / catalog number: 5109

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Manufacturer information

Organization name: AET Australasian European Trading GmbH
SRN: DE-MF-000009115
Manufacturer status: Active

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: 04250239440863
Basic UDI-DI: 42502394TSM110E4
Reference / catalog number: 5109
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: Offene Kniebandage, umfaßt das Kniegelenk sowie die angrenzenden Oberschenkel- (ca. 16 cm oberhalb Kniescheibe) und Unterschenkelbereich (ca. 14 cm unterhalb Kniescheibe), mit Patella-Aussparung. Breite am Rand Oberschenkel ca. 52 cm, an der Wade ca. 43 cm (jeweils ungedehnt), mit 3 Klettverschlüssen. Bandage ist geeignet für Patienten mit Kniegelenks-arthrosen oder Überlastungssyndromen wie Muskelschmerzen oder Sehnenansatzschmerzen, bei denen Bandagen zum Überziehen nicht geeignet sind, darüber hinaus bei denen der Oberschenkel-umfang über die üblichen Konfektionsmaße hinaus geht.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 25–55 MU10

EMDN nomenclature code(s)

Y061209KNEE ORTHOSES

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

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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.