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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

E - Guide Tint — Class I MDR by Vertex-Dental B.V.

MD Atlas
Vertex-Dental B.V.

EUDAMED last updated this device on Jul 25, 2024

E - Guide Tint

871942550NDSGA16T6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Vertex-Dental B.V.
UDI-DI code: 08719425500041
Reference / catalog number: NPENSGOR01000

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View device family (Basic UDI)

Manufacturer information

Organization name: Vertex-Dental B.V.
SRN: NL-MF-000019230
Manufacturer status: Active

Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

BE24/00000143Supplemented
Quality management systemNotified body: 1639Expiry: Jun 3, 2029

Critical warnings

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

CW082
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW090
EUDAMED did not publish a description for this code.
CW106
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: E - Guide Tint
UDI-DI code: 08719425500041
Basic UDI-DI: 871942550NDSGA16T6
Reference / catalog number: NPENSGOR01000
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: —
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

UDI-DI DataMatrix

Encoded

(01)08719425500041

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Q0102050199DENTISTRY RESINS - 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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