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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

HT4818 — Class I MDR by Helmut Hund GmbH

MD Atlas
Helmut Hund GmbH

EUDAMED last updated this device on Aug 18, 2022

HT4818

426074436LLK0604U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Helmut Hund GmbH
UDI-DI code: 04260744360044
Reference / catalog number: HT4818

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Manufacturer information

Organization name: Helmut Hund GmbH
SRN: DE-MF-000006335
Manufacturer status: Active

Related devices

019.9150.000426074436AFLMED5EOn the market 008.0387.0426074436H60035On the market 008.0359.0426074436H60035On the market 008.0384.0426074436H60035On the market 008.0356.0426074436H60035On 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 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Aug 6, 2021	Still on market
Austria	Aug 6, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260744360044
Basic UDI-DI: 426074436LLK0604U
Reference / catalog number: HT4818
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)

Z12029080VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES

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