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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

20204 — Class I MDR by Fysiotech OÜ

MD Atlas
Fysiotech OÜ

EUDAMED last updated this device on Aug 1, 2023

20204

4745010245202049F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysiotech OÜ
UDI-DI code: 04745010245022
Reference / catalog number: 20204

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Manufacturer information

Organization name: Fysiotech OÜ
SRN: EE-MF-000007651
Manufacturer status: Active

Market distribution

Primary placement in Estonia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04745010245022
Basic UDI-DI: 4745010245202049F
Reference / catalog number: 20204
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: Günekoloogiline laud
Additional information URL: https://www.fysiotech.ee/product/gyne-pluss-x1/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080603TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS

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.