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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

NextDent Ortho IBT — Class I MDR by Vertex-Dental B.V.

MD Atlas
Vertex-Dental B.V.

EUDAMED last updated this device on Jul 24, 2024

NextDent Ortho IBT

871942550NDOIA13S2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Vertex-Dental B.V.
UDI-DI code: 08720604633931
Reference / catalog number: NDOICL01000_01

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View device family (Basic UDI)

Manufacturer information

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

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Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Feb 15, 2024	Still on market

Device identification

Trade name: NextDent Ortho IBT
UDI-DI code: 08720604633931
Basic UDI-DI: 871942550NDOIA13S2
Reference / catalog number: NDOICL01000_01
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)08720604633931

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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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