Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

CH OUA 44x50 COUPE A PLAT — Class I MDR by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on Feb 14, 2024

CH OUA 44x50 COUPE A PLAT

3661379FAB1000001D2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379237465
Reference / catalog number: DF100003_A

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

DOUBLEFLO Day Tube Set3661379FAB020002AEFOn the market DOUBLEFLO OUTFLOW TUBE SET3661379FAB020002AEFOn the market DOUBLEFLO PATIENT TUBE SET3661379FAB020002AEFOn the market 4-way pedal for "ArthroVims pump"3661379FAB0400001E5On the market BOUCHON LLFE V1 PSB-03661379264065On the market

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

1 warning recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: CH OUA 44x50 COUPE A PLAT
UDI-DI code: 03661379237465
Basic UDI-DI: 3661379FAB1000001D2
Reference / catalog number: DF100003_A
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: Les champs ont pour but de limiter les infections lors du soin. Les champs sont des « draps » constitués d’un film imperméable et d’un substrat absorbant, laminés et collés ensemble. La destination médicale revendiquée pour les champs est différente selon la nature du champ : champ de soins ou champ de table. L’utilisation des champs de soins : permet la protection du patient afin de limiter le risque d’infection lors de la réalisation du soin, protège le patient des liquides et assure son confort pendant le soin. L’utilisation des champs de table : permet la protection de la zone de soins (telle qu’une table, un adaptable, le lit du patient ou tout autre support) dans le but de créer une surface de travail aseptique pour déposer les composants nécessaires au soin.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 44 MU10
50 MU10

EMDN nomenclature code(s)

T020199SURGICAL DRAPES - 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