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Organization name
UDI-DI code
Reference / catalog number

8300-01 — Class I MDR by RAMED Kopřivnice s.r.o.

MD Atlas
RAMED Kopřivnice s.r.o.

EUDAMED last updated this device on Apr 15, 2026

8300-01

859420869UOSWH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RAMED Kopřivnice s.r.o.
UDI-DI code: 08594208690078
Reference / catalog number: 8300-01

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Manufacturer information

Organization name: RAMED Kopřivnice s.r.o.
SRN: CZ-MF-000043587
Manufacturer status: Active

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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.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Oct 27, 2017	Dec 31, 9999
Slovakia		Dec 31, 9999

Device identification

Trade name: not provided
UDI-DI code: 08594208690078
Basic UDI-DI: 859420869UOSWH
Reference / catalog number: 8300-01
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011202OPERATING TABLES

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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