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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

SK8403 — Class I MDD by Tribo sp. z o.o.

MD Atlas
Tribo sp. z o.o.

EUDAMED last updated this device on Mar 27, 2024

SK8403

B-SK8403C4

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Tribo sp. z o.o.
UDI-DI code: D-SK8403C4
Reference / catalog number: SK8403

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View device family (Basic UDI)

Manufacturer information

Organization name: Tribo sp. z o.o.
SRN: PL-MF-000026942
Manufacturer status: Active

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

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-SK8403C4
Basic UDI-DI: B-SK8403C4
Reference / catalog number: SK8403
Issuing entity: EUDAMED

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: Taboret do badania pacjenta z ergonomicznym siedziskiem typ Sk8403 służy do wykonywania badań i innych czynności medycznych na pacjencie w pozycji siedzącej w placówkach służby zdrowia. Maksymalne obciążenie nie powinno przekraczać 140kg.
Additional information URL: https://tribo.com.pl/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-SK8403C4

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V080299MEDICAL CHAIRS - 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

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