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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

RACCORDS DE DIALYSE + SITE INJ — Class IIa MDD by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on May 9, 2025

RACCORDS DE DIALYSE + SITE INJ

B-03661379259474

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379259474
Reference / catalog number: 9100_C

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Manufacturer information

Organization name: HEMODIA SAS
SRN: FR-MF-000007191
Manufacturer status: Active

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

3 warnings recorded — scroll inside the panel to see all entries.

CW001
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW999
Ne pas utiliser sur une population pédiatrique (nouveaux nés, nouveaux nés prématurés ou nourrissons).

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: RACCORDS DE DIALYSE + SITE INJ
UDI-DI code: 03661379259474
Basic UDI-DI: B-03661379259474
Reference / catalog number: 9100_C
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Les tubulures de la gamme dialyse sont des dispositifs médicaux utilisés pour le traitement des patients souffrant d’insuffisance rénale chronique terminale et bénéficiant d'une suppléance rénale : hémodialyse. Ce raccord connecte la fistule ou le cathéter du patient (2 points de ponction) à la ligne artérielle ou veineuse. La longueur supplémentaire apportée entre le patient et le générateur permet d’éviter les risques de plicatures de la tubulure. Ce type de raccord peut présenter un site d’injection permettant d’injecter des solutions dans le sang pendant la séance de dialyse (bolus NaCl).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

F0299DIALYSIS LINES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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