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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

Harn2 — Class I MDR by MDB TEXINOV

MD Atlas
MDB TEXINOV

EUDAMED last updated this device on Jan 12, 2026

Harn2

3770021816HARNAISB2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MDB TEXINOV
UDI-DI code: 03770021816009
Reference / catalog number: HARN2 Harnais

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Manufacturer information

Organization name: MDB TEXINOV
SRN: FR-MF-000001728
Manufacturer status: Active

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Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: Harn2
UDI-DI code: 03770021816009
Basic UDI-DI: 3770021816HARNAISB2
Reference / catalog number: HARN2 Harnais
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: 1
Additional product description: —
Additional information URL: https://www.fluxmedicare.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040280GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.