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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

COPRA6 RM1 — Class IIa MDR by COPRA System GmbH

MD Atlas
COPRA System GmbH

EUDAMED last updated this device on Sep 27, 2022

COPRA6 RM1

426073712COPRA67Q

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: COPRA System GmbH
UDI-DI code: 04260737120013
Reference / catalog number: COPRA6 RM1

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Manufacturer information

Organization name: COPRA System GmbH
SRN: DE-MF-000007325
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Dec 12, 2017	Mar 31, 2024

Device identification

Trade name: not provided
UDI-DI code: 04260737120013
Basic UDI-DI: 426073712COPRA67Q
Reference / catalog number: COPRA6 RM1
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://copra-system.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - 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

Related devices

This device is not currently linked to any other device.

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.