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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

Gelmax® Sachet dose hydrosoluble… — Class I MDR by CLEANIS

MD Atlas
CLEANIS

EUDAMED last updated this device on Aug 27, 2025

Gelmax® Sachet dose hydrosoluble 600, x 100

376005923RECUEILEXCDT02B2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CLEANIS
UDI-DI code: 03760059239864
Reference / catalog number: 9578420

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Manufacturer information

Organization name: CLEANIS
SRN: FR-MF-000004677
Manufacturer status: Active

Critical warnings

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

CW999
Ne pas utiliser ce produit pour gélifier les produits chimiques suivants : acides forts, bases fortes (concentrations>3%), (concentrations>10%) et agents oxydants forts. Ne pas manipuler avec les mains humides. En cas de contact de la poudre avec l'œil ou les muqueuses, rincer abondamment à l'eau. En cas de gêne persistante, contacter votre médecin. Ne pas laisser à la portée des enfants

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: Gelmax® Sachet dose hydrosoluble 600, x 100
UDI-DI code: 03760059239864
Basic UDI-DI: 376005923RECUEILEXCDT02B2
Reference / catalog number: 9578420
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: 100
Additional product description: Sachet-dose hydrosoluble contenant de la poudre de polymères super-absorbants(SAP)(capacité d’absorption de 600ml saline0,9%,équivalent fluides biologiques) destiné à la gélification des fluides corporels dans des petits contenants–poches de stomies retirées du patient, bocaux d’aspiration
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0880MEDICAL SUPPORT EQUIPMENT - 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

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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.