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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

M18OT — IVDD — General IVDD by Orphée SA

MD Atlas
Orphée SA

EUDAMED last updated this device on Feb 13, 2026

M18OT

B-07640142480396

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Orphée SA
UDI-DI code: 07640142480396
Reference / catalog number: M18OT

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Manufacturer information

Organization name: Orphée SA
SRN: CH-MF-000050926
Manufacturer status: Active

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M3CRPB-07640142480464On the market HM22-001-1764014248HM22-001YTOn the market HM22-003-10764014248HM22-003YXOn the market MYT3CRPB-07640142480587On the market MYTCAL1-CRPB-07640142480556On 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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07640142480396
Basic UDI-DI: B-07640142480396
Reference / catalog number: M18OT
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Automated hematology analyser
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010201AUTOMATED 3 PART HEMATOLOGY ANALYSERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Software identification