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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

90229 — IVDR Class A IVDR by HYDREX DIAGNOSTICS Sp.…

MD Atlas
HYDREX DIAGNOSTICS Sp. z o. o.

EUDAMED last updated this device on Feb 9, 2024

90229

5905669217PLYTY.SEROLOG9L

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: HYDREX DIAGNOSTICS Sp. z o. o.
UDI-DI code: 05908217979926
Reference / catalog number: 90229

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View device family (Basic UDI)

Manufacturer information

Organization name: HYDREX DIAGNOSTICS Sp. z o. o.
SRN: PL-MF-000010271
Manufacturer status: Active

Related devices

902325905669217PLYTY.SEROLOG9LOn the market 902275905669217PLYTY.SEROLOG9LOn the market 902255905669217PLYTY.SEROLOG9LOn the market 902265905669217PLYTY.SEROLOG9LOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05908217979926
Basic UDI-DI: 5905669217PLYTY.SEROLOG9L
Reference / catalog number: 90229
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 100
Additional product description: Manual Plate is intended to be used to perform the qualitative determination of blood groups and phenotype for manual agglutination method using liquid reagents.
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)05908217979926

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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.

W05039080DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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