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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

alea Clip — Class I MDR by AssistMe GmbH

MD Atlas
AssistMe GmbH

EUDAMED last updated this device on Apr 28, 2025

alea Clip

42557126ASSISTMEALEA5E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AssistMe GmbH
UDI-DI code: 04255712603797
Reference / catalog number: AL00011

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Manufacturer information

Organization name: AssistMe GmbH
SRN: DE-MF-000039002
Manufacturer status: Active

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: alea Clip
UDI-DI code: 04255712603797
Basic UDI-DI: 42557126ASSISTMEALEA5E
Reference / catalog number: AL00011
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T99PROTECTIVE DEVICES AND AIDS FOR INCONTINENCE (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER

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

alea Software42557126ASSISTMEALEA5EOn the market Docking Station42557126ASSISTMEALEA5EOn 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.