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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

MFG02001 — IVDD — Annex II List B IVDD by BGI EUROPE A/S

MD Atlas
BGI EUROPE A/S

EUDAMED last updated this device on Mar 31, 2026

MFG02001

B-05745000468119

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BGI EUROPE A/S
UDI-DI code: 05745000468119
Reference / catalog number: MFG02001

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Manufacturer information

Organization name: BGI EUROPE A/S
SRN: DK-MF-000014089
Manufacturer status: Active

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 Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Jun 30, 2020	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: 05745000468119
Basic UDI-DI: B-05745000468119
Reference / catalog number: MFG02001
Issuing entity: GS1

Classification

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

Device details

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

EMDN nomenclature code(s)

W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

MFG020003B-05745000468072On the market MFG030008B-05745000468126On the market MFG030009B-05745000468133On the market MFG030007B-05745000468096On the market MFG020007B-05745000468508On 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.