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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

U2012 — Class I MDR by ATO FORM GmbH

MD Atlas
ATO FORM GmbH

EUDAMED last updated this device on May 21, 2026

U2012

42511106AQUATHERKA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ATO FORM GmbH
UDI-DI code: 04251110629551
Reference / catalog number: U2012

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Manufacturer information

Organization name: ATO FORM GmbH
SRN: DE-MF-000008880
Manufacturer status: Active

Related devices

BS-0100-642511106BSZUBC6On the market BSZ-201-5550-642511106BSZUBC6On the market BSZ-301-8550-642511106BSZUBC6On the market TS-14942511106TSZUBJCOn the market TS-15042511106TSZUBJCOn 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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251110629551
Basic UDI-DI: 42511106AQUATHERKA
Reference / catalog number: U2012
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: Incontinence watertherapy suit Aquather
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0499INCONTINENCE DEVICES - 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
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Software identification