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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

BoneMRI — Class IIa MDR by MRIguidance B.V.

MD Atlas
MRIguidance B.V.

EUDAMED last updated this device on Jun 22, 2023

BoneMRI

87193269751BMRI-BND

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MRIguidance B.V.
UDI-DI code: 08719326975160
Reference / catalog number: v1.6

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View device family (Basic UDI)

Manufacturer information

Organization name: MRIguidance B.V.
SRN: NL-MF-000002682
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 2 countries total.

Country	On market since	Until
NetherlandsPrimary placement	Dec 22, 2022	Dec 22, 2026
Belgium	Dec 22, 2022	Dec 22, 2026

Device identification

Trade name: BoneMRI
UDI-DI code: 08719326975160
Basic UDI-DI: 87193269751BMRI-BND
Reference / catalog number: v1.6
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)08719326975160

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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.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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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Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

23M00065CRT01Issued
Quality management systemNotified body: 1912Expiry: Dec 2, 2028