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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

V008817 — Class I MDR by Hubert De Backer nv

MD Atlas
Hubert De Backer nv

EUDAMED last updated this device on May 29, 2026

V008817

5400995DosingApplicatorSD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hubert De Backer nv
UDI-DI code: 05400995001894
Reference / catalog number: V008817

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View device family (Basic UDI)

Manufacturer information

Organization name: Hubert De Backer nv
SRN: BE-MF-000020418
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

BE24/00000031Issued
Quality assuranceNotified body: 1639Expiry: Feb 9, 2029

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Jan 19, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05400995001894
Basic UDI-DI: 5400995DosingApplicatorSD
Reference / catalog number: V008817
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: 1250
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05400995001894

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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.

A020299REUSABLE SYRINGES - OTHER

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

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