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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

ALGIKENT A SACHET (12 x500 G) — Class I MDD by CONCEPTION ET…

MD Atlas
CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX

EUDAMED last updated this device on Apr 4, 2022

ALGIKENT A SACHET (12 x500 G)

B-120874MX

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX
UDI-DI code: D-120874MX
Reference / catalog number: 120874

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Manufacturer information

Organization name: CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX
SRN: FR-MF-000010345
Manufacturer status: Active

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
France		Still on market

Device identification

Trade name: ALGIKENT A SACHET (12 x500 G)
UDI-DI code: D-120874MX
Basic UDI-DI: B-120874MX
Reference / catalog number: 120874
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Alginates are homogeneous powders with different colors and flavors depending on the type of product. The product has to be mixed with water to achieve a homogeneous paste that will be positioned on the tray and then in the patient's mouth. Mixing powder with water implies the production of strong intermolecular crosslinking bonds between polysaccharide chains and divalent cations. They are intended to be used for dental impression in the dental clinics.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01020101DENTAL IMPRESSION ALGINATES

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.