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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

80210100 — Class I MDR by flow-med GmbH

MD Atlas
flow-med GmbH

EUDAMED last updated this device on Jun 19, 2024

80210100

4260277010026F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: flow-med GmbH
UDI-DI code: 04260277017019
Reference / catalog number: 80210100

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Manufacturer information

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

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: 04260277017019
Basic UDI-DI: 4260277010026F
Reference / catalog number: 80210100
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: Electronic drying station for cochlear implants. Global-version, brown/silver incl. Universal USB power supply, Adapter EU, US, UK, AUS, Instruction for use
Additional information URL: https://downloads.flow-med.com/user_guide_dry-space_uv.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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.