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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

HG400F — Class I MDR by FRELU GmbH

MD Atlas
FRELU GmbH

EUDAMED last updated this device on Apr 28, 2026

HG400F

PP11813Y181803.I.A55

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FRELU GmbH
UDI-DI code: 1311813HG400F128
Reference / catalog number: HG400F

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Manufacturer information

Organization name: FRELU GmbH
SRN: DE-MF-000042760
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW011
max. Belastung 150 kg

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market

Device identification

Trade name: not provided
UDI-DI code: 1311813HG400F128
Basic UDI-DI: PP11813Y181803.I.A55
Reference / catalog number: HG400F
Issuing entity: IFA

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)

Y181803HANDRAILS

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

Related devices

HG1000FPP11813Y181803.I.A55On the market HG1240GPP11813Y181803.I.A55On the market HG1300FPP11813Y181803.I.A55On the market HG1500FPP11813Y181803.I.A55On the market HG1100FPP11813Y181803.I.A55On 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.