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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

1091 — Class IIb MDD by GME German Medical…

MD Atlas
GME German Medical Engineering GmbH

EUDAMED last updated this device on May 29, 2024

1091

B-B12510910

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: GME German Medical Engineering GmbH
UDI-DI code: B12510910
Reference / catalog number: 1091

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Manufacturer information

Organization name: GME German Medical Engineering GmbH
SRN: DE-MF-000009384
Manufacturer status: Active

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	Jun 21, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: B12510910
Basic UDI-DI: B-B12510910
Reference / catalog number: 1091
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: The MED-UV device is a portable phototherapy system.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 0–2 MU103

EMDN nomenclature code(s)

Z12040202PHOTOTHERAPY EQUIPMENT

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

1070B-+B12510700POn the market 1050B-+B12510500NOn the market 1091++B1251090UMOn the market 1092++B1251090UMOn the market 1060B-+B12510600OOn 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.