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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

5943065001030 — Class I MDR by Dr. Soleil Produse…

MD Atlas
Dr. Soleil Produse Cosmetice SRL

EUDAMED last updated this device on Jul 13, 2022

5943065001030

5943065GELECOGRAFICD6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Soleil Produse Cosmetice SRL
UDI-DI code: 59430650010306
Reference / catalog number: 5943065001030

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View device family (Basic UDI)

Manufacturer information

Organization name: Dr. Soleil Produse Cosmetice SRL
SRN: RO-MF-000018756
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Placed on the market in Romania; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 59430650010306
Basic UDI-DI: 5943065GELECOGRAFICD6
Reference / catalog number: 5943065001030
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: Se aplica pe piele o cantitate suficienta de gel, pentru a asigura priza cu sonda ecografica. Dupa examinare, gelul se indeparteaza cu un servetel. Exclusiv pentru investigatii clinice. Produsul nu este toxic pentru organismul pacientului. Nu participa in procesele fiziologice ale organismului. Este compatibil cu tegumentul pe care se aplica, tinandu-se cont de scopul propus al dispozitivului.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)59430650010306

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11040185ULTRASOUND SCANNERS - CONSUMABLES

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

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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.