Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

TSM forearm sleeve active — Class I MDR by AET Australasian…

MD Atlas
AET Australasian European Trading GmbH

EUDAMED last updated this device on Dec 7, 2023

TSM forearm sleeve active

42502394TSM113EA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AET Australasian European Trading GmbH
UDI-DI code: 04250239410408
Reference / catalog number: 2111

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

517442502394TSM110E4On the market TSM ankle support PRO with stabilization strap, left42502394TSM105EBOn the market TSM ankle support PRO with stabilization strap, right42502394TSM105EBOn the market TSM ankle support with stabilization straps and stays, left42502394TSM005E6On the market TSM ankle support with stabilization straps and stays, right42502394TSM005E6On 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: TSM forearm sleeve active
UDI-DI code: 04250239410408
Basic UDI-DI: 42502394TSM113EA
Reference / catalog number: 2111
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: Support covers the wrist (wrist bone region) and approximately two thirds of the forearm. The elastic, 2 mm thick neoprene means that pulling the support on is very easy; the fit of the support is optimal when it fits snugly between forearm and wrist without pinching. The support is particularly suitable for protecting the forearm region from external influences, for example, when playing volleyball.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 11–23 MU10

EMDN nomenclature code(s)

Y060609WRIST (FOREARM) 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