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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

0007.1.34 — Class I MDR by Hydas GmbH & Co. KG

MD Atlas
Hydas GmbH & Co. KG

EUDAMED last updated this device on Sep 19, 2022

0007.1.34

4004128InkontinenzhosenHT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hydas GmbH & Co. KG
UDI-DI code: 04004128032130
Reference / catalog number: 0007.1.34

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Manufacturer information

Organization name: Hydas GmbH & Co. KG
SRN: DE-MF-000016598
Manufacturer status: Active

Critical warnings

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

CW999
Intended purpose The incontinence pants are worn like usual underwear. It is used to alleviate the effects of mild to moderate incontinence associated with an absorbent pad. • Mild to moderate urinary / fecal incontinence associated with

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: 04004128032130
Basic UDI-DI: 4004128InkontinenzhosenHT
Reference / catalog number: 0007.1.34
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: 100% Baumwolle, Nässeschutz Polyolefin, 95° waschbar, Trockner geeignet 100% Baumwolle, Nässeschutz Polyolefin 95° waschbar Trockner geeignet Technische Daten: Farbe: weiß Material: 100% Baumwolle 100% Polyolefin - Nässeschutz Ursprungsland: Griechenland
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

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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.