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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

Q EDTA Gel (EDTA Gel 15%), 10 ml — Class IIa MDD by J RIPOLL SL

MD Atlas
J RIPOLL SL

EUDAMED last updated this device on May 29, 2025

Q EDTA Gel (EDTA Gel 15%), 10 ml

B-08436042241095

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: J RIPOLL SL
UDI-DI code: 08436042241095
Reference / catalog number: QCR10

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Manufacturer information

Organization name: J RIPOLL SL
SRN: ES-MF-000001256
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.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Jan 1, 1990	May 29, 2025
Italy	Jan 1, 1990	May 29, 2025

Device identification

Trade name: Q EDTA Gel (EDTA Gel 15%), 10 ml
UDI-DI code: 08436042241095
Basic UDI-DI: B-08436042241095
Reference / catalog number: QCR10
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: 1 jeringa de 10 ml + 6 puntas negras + prospecto
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0101010299TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - 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

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Software identification