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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

HT-HSG2P — IVDD — General IVDD by Halotech DNA

MD Atlas
Halotech DNA

EUDAMED last updated this device on Jul 8, 2025

HT-HSG2P

B-08437024427094

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Halotech DNA
UDI-DI code: 08437024427094
Reference / catalog number: HT-HSG2P

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Manufacturer information

Organization name: Halotech DNA
SRN: ES-MF-000001921
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
Care should be taken to avoid contact with skin or eyes, and to prevent inhalation. The acid solution (DA) contains Hydrochloric acid, and the lysis solution (LS) contains Dithiothreitol and Triton X-100. Work under air removal environment and follow the manufacturer’s Material Safety Data regarding safe handling.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08437024427094
Basic UDI-DI: B-08437024427094
Reference / catalog number: HT-HSG2P
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Kit for measurement of DNA fragmentation level of spermatozoa.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01019099CLINICAL CHEMISTRY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.