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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

HELIOTONE+ HOT FAST VR4 Powder1 kg — Class I MDR

MD Atlas
EVERALL7 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on May 18, 2025

HELIOTONE+ HOT FAST VR4 Powder1 kg

590160212DBQ3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EVERALL7 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
UDI-DI code: 05901602128992
Reference / catalog number: 3166925

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View device family (Basic UDI)

Manufacturer information

Organization name: EVERALL7 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000018646
Manufacturer status: Active

Related devices

HELIOTONE+ AUTO liquid 200 ml590160212REPFPOn the market HELIOTONE+ AUTO liquid 50 ml590160212REPFPOn the market HELIOTONE+ AUTO liquid 500 ml590160212REPFPOn the market HELIOTONE+ AUTO VR4 100g + 50 ml590160212REPFPOn the market HELIOTONE+ AUTO VR4 powder 1 kg590160212REPFPOn 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

2 warnings recorded — scroll inside the panel to see all entries.

CW999
Do not use the products by people diagnosed with a lack of resistance to allergenic factors, including the ingredients of the product. In such situations, use a different material suitable for the patient.
CW999
Do not use the product by pregnant women and nursing mothers in the group of dental technicians.

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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: HELIOTONE+ HOT FAST VR4 Powder1 kg
UDI-DI code: 05901602128992
Basic UDI-DI: 590160212DBQ3
Reference / catalog number: 3166925
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: Acrylic resin for denture bases, fast thermal curing.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - 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

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