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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

R1 — Class IIa MDR by Ropca Aps

MD Atlas
Ropca Aps

EUDAMED last updated this device on Mar 26, 2026

R1

57000022093R1QY

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ropca Aps
UDI-DI code: 05700002209306
Reference / catalog number: R1

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Manufacturer information

Organization name: Ropca Aps
SRN: DK-MF-000011938
Manufacturer status: Active

Related devices

D157000022093D1PNOn 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.

CW999
Please follow the contraindications from the connected ultrasound device.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Sep 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05700002209306
Basic UDI-DI: 57000022093R1QY
Reference / catalog number: R1
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11049080VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES

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