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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

60410100 — Class I MDR by flow-med GmbH

MD Atlas
flow-med GmbH

EUDAMED last updated this device on Jun 19, 2024

60410100

4260277010066P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: flow-med GmbH
UDI-DI code: 04260277011574
Reference / catalog number: 60410100

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Manufacturer information

Organization name: flow-med GmbH
SRN: DE-MF-000006336
Manufacturer status: Active

Related devices

905101004260277010046KOn the market 910101004260277010096VOn the market 911101004260277010096VOn the market 912101004260277010096VOn the market 704202014260277010026FOn 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.

Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260277011574
Basic UDI-DI: 4260277010066P
Reference / catalog number: 60410100
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: Rechargeable mini ultrasonic cleaner. Global-version, white/anthracite incl. USB-C cable, Packaging, Cleaning cloth, Instruction for use
Additional information URL: https://downloads.flow-med.com/user_guide_u-sonic3.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214580HEARING AIDS OR HEARING DEVICES - 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

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