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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

MRK521PG — Class IIa MDR by RK INNOV SAS

MD Atlas
RK INNOV SAS

EUDAMED last updated this device on Jan 10, 2023

MRK521PG

03770018797MyoRKCL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RK INNOV SAS
UDI-DI code: 03770018797144
Reference / catalog number: MRK521PG

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Manufacturer information

Organization name: RK INNOV SAS
SRN: FR-MF-000028533
Manufacturer status: Active

Related devices

MRK941PG03770018797MyoRKCLOn the market MRK731PG03770018797MyoRKCLOn the market MyoRK03770018797MyoRKCLOn 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.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770018797144
Basic UDI-DI: 03770018797MyoRKCL
Reference / catalog number: MRK521PG
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: same as MRK941PG 5 flexibles 2 programmable channels
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120611VACUUM THERAPY EQUIPMENT

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
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Software identification