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Organization name
UDI-DI code
Reference / catalog number

TUBULURE DE SAIGNEE — Class IIa MDD by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on Jan 12, 2024

TUBULURE DE SAIGNEE

B-03661379245361

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379245361
Reference / catalog number: 9200_A

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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 pour une autre opération que celle de saignée/phlebotomie. Ne revendique pas les Don-Saignées : le sang extrait doit être jeté. Le site de prélèvement n'est pas fait pour l'injection de produit.

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: TUBULURE DE SAIGNEE
UDI-DI code: 03661379245361
Basic UDI-DI: B-03661379245361
Reference / catalog number: 9200_A
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: Cette tubulure est destinée à la réalisation d’une saignée, encore appelée phlébotomie dans le cadre du traitement de l’hémochromatose héréditaire. La tubulure est connectée dans sa partie proximale à un cathéter court ou microperfuseur de gros calibre et à l’autre extrémité à un système d’aspiration sous vide appelé flacon de Redon. Le sang extrait du patient ne sera pas réutilisé (protocole don-saignée différent).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A0380TUBULAR DEVICES - 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