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Organization name
UDI-DI code
Reference / catalog number

BIDON EAU STERILE 5L — Class I MDR by Laboratoire Aguettant

MD Atlas
Laboratoire Aguettant

EUDAMED last updated this device on Sep 9, 2024

BIDON EAU STERILE 5L

37005677BIDON-EAU26

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoire Aguettant
UDI-DI code: 03700567702511
Reference / catalog number: 64398

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Manufacturer information

Organization name: Laboratoire Aguettant
SRN: FR-MF-000000509
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

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

Device identification

Trade name: BIDON EAU STERILE 5L
UDI-DI code: 03700567702511
Basic UDI-DI: 37005677BIDON-EAU26
Reference / catalog number: 64398
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: Sterile water 5L is used for rinsing medical or surgical instruments or equipment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011385CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES

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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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.