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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

RACCORD Y POUR UNIPONCTURE GAM — Class IIa MDD by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on Aug 8, 2023

RACCORD Y POUR UNIPONCTURE GAM

B-03661379056561

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379056561
Reference / catalog number: 0095_C

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Manufacturer information

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

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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). Ne pas utiliser sur une ligne à sang biponcture.

Market distribution

Primary placement in France; available across 2 countries total.

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

Device identification

Trade name: RACCORD Y POUR UNIPONCTURE GAM
UDI-DI code: 03661379056561
Basic UDI-DI: B-03661379056561
Reference / catalog number: 0095_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. Elles sont utilisées pour transporter le sang ou d’autres liquides depuis l’accès vasculaire du patient vers l’unité appropriée du dialyseur (hémodialyseur) pour leur traitement.
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
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Software identification