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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

500537 — Class I MDD by Pharmpur GmbH

MD Atlas
Pharmpur GmbH

EUDAMED last updated this device on Jun 3, 2022

500537

B-04260260050757

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Pharmpur GmbH
UDI-DI code: 04260260050757
Reference / catalog number: 500537

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Manufacturer information

Organization name: Pharmpur GmbH
SRN: DE-MF-000008337
Manufacturer status: Active

Critical warnings

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

CW009
Disposable product. Not suitable for reuse.
CW001
Reprocessing and re-sterilisation are not permitted. The following risks can arise from unauthorised reprocessing and re-sterilisation: Infection due to insufficient sterility and/or biological contamination. Reprocessing can lead to invisible damage to the device and thus to insufficient functionality.
CW007
Do not use the product if the packaging is opened or damaged or if you have doubts about the sterility of the product.
CW032
Expiry date
CW010
This device may only be used in accordance with these instructions for use.

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: 04260260050757
Basic UDI-DI: B-04260260050757
Reference / catalog number: 500537
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: ophthafutur safelight is a handheld, wireless, and battery powered transscleral illumination device. It is for single use only. ophthafutur safelight is supplied sterile. ophthafutur safelight contains a white LED. ophthafutur safelight does not emit light below 400nm or above 840nm.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L1799OPHTHALMOLOGY INSTRUMENTS, REUSABLE- 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

S100/500576B-04260260050764On the market 500513B-04260260050269On the market 500514B-04260260050276On the market 500500B-04260260050139On the market 500501B-04260260050146On 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.