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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

15000006 — Class I MDR by UFSK-International OSYS…

MD Atlas
UFSK-International OSYS GmbH

EUDAMED last updated this device on Jun 12, 2024

15000006

4057027TC001LG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UFSK-International OSYS GmbH
UDI-DI code: 04057027609606
Reference / catalog number: 15000006

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Manufacturer information

Organization name: UFSK-International OSYS GmbH
SRN: DE-MF-000013511
Manufacturer status: Active

Related devices

140000014057027TT001Q7On the market 1500000084057027TC002LJOn the market 150000054057027TC001LGOn the market 240000154057027AC001DXOn the market 240000054057027AC001DXOn 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.

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

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: 04057027609606
Basic UDI-DI: 4057027TC001LG
Reference / catalog number: 15000006
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: Treatment chair for positioning and support of the patient for outpatient microsurgical treatments in ophthalmology, ENT and dental surgery
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V08020101GENERIC USE ELECTRIC MEDICAL CHAIRS

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

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Software identification