Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

MFG030008 — 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

MFG030008

B-05745000468126

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: 05745000468126
Reference / catalog number: MFG030008

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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	Dec 4, 2019	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: 05745000468126
Basic UDI-DI: B-05745000468126
Reference / catalog number: MFG030008
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: There are three specifications of this product, each specification contains 3 boxes, this is loading capacity II. The UDI-DI of capacity box 1 is:05745000468126.The UDI-DI of capacity box 2 is: 05745000468423; The UDI-DI of capacity box 3 is: 05745000468430
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010304PÄTAU SYNDROME
W0106010302EDWARDS SYNDROME
W0106010301DOWN'S SYNDROME

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 MFG02001B-05745000468119On 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.