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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

4260324141209 — Class I MDR by Bernhard Klein e.K.

MD Atlas
Bernhard Klein e.K.

EUDAMED last updated this device on Jul 8, 2025

4260324141209

426032414BIORELAXHR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bernhard Klein e.K.
UDI-DI code: 04260324141209
Reference / catalog number: 4260324141209

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Manufacturer information

Organization name: Bernhard Klein e.K.
SRN: DE-MF-000021891
Manufacturer status: Active

Critical warnings

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

CW010
Siehe Gebrauchsanweisung
CW261
Siehe Gebrauchsanweisung und Kennzeichnungen

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: 04260324141209
Basic UDI-DI: 426032414BIORELAXHR
Reference / catalog number: 4260324141209
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)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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

04260324140219426032414BIORELAXHROn the market 4260324140707426032414BIORELAXHROn the market 4260324140714426032414BIORELAXHROn the market 4260324140721426032414BIORELAXHROn the market 4260324140738426032414BIORELAXHROn 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.