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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

9910.1.00 — Class I MDR by Hydas GmbH & Co. KG

MD Atlas
Hydas GmbH & Co. KG

EUDAMED last updated this device on Nov 1, 2022

9910.1.00

4004128TriggerU5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hydas GmbH & Co. KG
UDI-DI code: 04004128007664
Reference / catalog number: 9910.1.00

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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
• Den Triggerknopf mit warmem Seifenwasser reinigen und mit klarem Wasser abspülen. Bei Bedarf ein Desinfektionsmittel benutzen. Keine scharfen oder scheuernden Reinigungsmittel oder Reinigungspads verwenden. Diese können die Oberflflächen beschädigen. • Den Triggerknopf vor dem Verstauen mit einem Tuch abtrocknen oder an der Luft trocknen lassen. • Bei Zimmertemperatur (zwischen 4 und 25 °C) und vor Sonnenlicht geschützt außerhalb der Reichweite von Kindern und Tieren aufbewahren.

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: 04004128007664
Basic UDI-DI: 4004128TriggerU5
Reference / catalog number: 9910.1.00
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: Das Produkt wird bei lateralem Ellenbogenschmerz, lateralem Schienbeinkantensyndrom oder Muskelverspannungen im Schulter-Nacken-Bereich eingesetzt.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120602PHYSIOTHERAPY EQUIPMENT

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.