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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

Villacryl Base powder 100g color V4 — Class I MDR

MD Atlas
EVERALL7 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Jun 18, 2024

Villacryl Base powder 100g color V4

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: 05901602123539
Reference / catalog number: V280V4P06

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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

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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.

Critical warnings

3 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.
CW129
Contains Dibenzoyl Peroxide. May produce an allergic reaction

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: Villacryl Base powder 100g color V4
UDI-DI code: 05901602123539
Basic UDI-DI: 590160212DBQ3
Reference / catalog number: V280V4P06
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: Heat Curing acrylic resin for making mobile dental prostheses. Powder 100g. Must be used together with compatible acrylic liquid.
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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