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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

000-150 — Class IIa MDR by Quantib BV

MD Atlas
Quantib BV

EUDAMED last updated this device on Jul 25, 2024

000-150

8719689791PGNDQM

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Quantib BV
UDI-DI code: 08719689791254
Reference / catalog number: 000-150

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View device family (Basic UDI)

Manufacturer information

Organization name: Quantib BV
SRN: NL-MF-000027601
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

SCAR-13.2.2.1Amended
Quality management systemNotified body: 3022Expiry: Aug 1, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08719689791254
Basic UDI-DI: 8719689791PGNDQM
Reference / catalog number: 000-150
Issuing entity: GS1

Classification

Risk category: Class IIa
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)08719689791254

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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.

Z119082VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES

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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