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Organization name
UDI-DI code
Reference / catalog number

SKALA OK3-V1 Perfusion set — Class IIa MDD by GAMA GROUP a.s.

MD Atlas
GAMA GROUP a.s.

EUDAMED last updated this device on Jun 2, 2022

SKALA OK3-V1 Perfusion set

B-08593540505651

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: GAMA GROUP a.s.
UDI-DI code: 08593540505651
Reference / catalog number: V606501-01

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Manufacturer information

Organization name: GAMA GROUP a.s.
SRN: CZ-MF-000011894
Manufacturer status: Active

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Critical warnings

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

CW011
Čtěte návod k použití
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: SKALA OK3-V1 Perfusion set
UDI-DI code: 08593540505651
Basic UDI-DI: B-08593540505651
Reference / catalog number: V606501-01
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V80CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES

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

Certificate health across this manufacturer's portfolio.

26 0129 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Apr 29, 2031
23 0517 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Nov 9, 2028