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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

PW0.0008.583 — Class I MDR by Lehnen GmbH

MD Atlas
Lehnen GmbH

EUDAMED last updated this device on Sep 14, 2022

PW0.0008.583

4250365200001QJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lehnen GmbH
UDI-DI code: 07640173710783
Reference / catalog number: PW0.0008.583

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Manufacturer information

Organization name: Lehnen GmbH
SRN: DE-MF-000025229
Manufacturer status: Active

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Critical warnings

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

CW018
Montageanleitung beachten!

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: 07640173710783
Basic UDI-DI: 4250365200001QJ
Reference / catalog number: PW0.0008.583
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: Haltegriffe werden rund um Badewanne, Dusche und Waschtisch eingesetzt. Sie dienen dabei als Ein- und Ausstiegshilfe und sorgen für einen sicheren Halt.
Additional information URL: https://www.nosag.ch/_files/ugd/fa6512_1bfc2a622489480f9d4d48e5bb6a4e88.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y181806HANDLES

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

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.