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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

60655001 — Class I MDR by SC MEBRA SRL

MD Atlas
SC MEBRA SRL

EUDAMED last updated this device on Jun 10, 2024

60655001

5944737mebragelCT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC MEBRA SRL
UDI-DI code: 05944737000320
Reference / catalog number: 60655001

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View device family (Basic UDI)

Manufacturer information

Organization name: SC MEBRA SRL
SRN: RO-MF-000017978
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: 05944737000320
Basic UDI-DI: 5944737mebragelCT
Reference / catalog number: 60655001
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: Dispozitiv medical neinvaziv temporar Gel ecografic incolor, utilizat in cadrul diagnosticarii imagistice cu ultrasunete in scopul de a facilita alunecarea sondei ecografice pe suprafata pielii si pentru a forma un mediu conductor intre transductor si pielea pacientului. Este ambalat in flacon PET transparent de 5L.
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)05944737000320

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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.

Z11049085VARIOUS ULTRASOUND INSTRUMENTS - 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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60655001B-05944737000320On the market 60655000B-05944737000313On the market 31847015B-05943079000470On the market 50000012B-05944737000245On the market 500000125944737mebragelCTOn 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.