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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

Geratherm® early detect — IVDD — Self-testing IVDD

MD Atlas
Geratherm Medical GERMANY GmbH

EUDAMED last updated this device on Jun 12, 2023

Geratherm® early detect

B-4018674GTPST01ZBM4

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Geratherm Medical GERMANY GmbH
UDI-DI code: D-4018674GTPST01ZBM4
Reference / catalog number: 9750000110

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Manufacturer information

Organization name: Geratherm Medical GERMANY GmbH
SRN: DE-MF-000007307
Manufacturer status: Active

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: Geratherm® early detect
UDI-DI code: D-4018674GTPST01ZBM4
Basic UDI-DI: B-4018674GTPST01ZBM4
Reference / catalog number: 9750000110
Issuing entity: EUDAMED

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic 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)

W0102160302HCG - RT & POC

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

Certificates

Certificate health across this manufacturer's portfolio.

HZ 2616312-1Issued
Quality management systemNotified body: 0197Expiry: Nov 10, 2029