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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

B-SP-IMC-00-000-000-0013 — Class IIa MDR by ReDent Nova GmbH

MD Atlas
ReDent Nova GmbH

EUDAMED last updated this device on Mar 31, 2025

B-SP-IMC-00-000-000-0013

426235751IRL0015F

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ReDent Nova GmbH
UDI-DI code: 04262357510113
Reference / catalog number: B-SP-IMC-00-000-000-0013

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View device family (Basic UDI)

Manufacturer information

Organization name: ReDent Nova GmbH
SRN: DE-MF-000032545
Manufacturer status: Active

Related devices

SF-10-150-021-0057426235751SAF0012COn the market SF-10-150-025-0058426235751SAF0012COn the market B-SA-CRD-00-000-000-0890426235751CSM0013KOn the market B-SA-IMC-00-000-000-0784426235751MCD001Y3On the market B-SA-IMC-00-000-000-0839426235751MCD001Y3On the market

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

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Dec 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262357510113
Basic UDI-DI: 426235751IRL0015F
Reference / catalog number: B-SP-IMC-00-000-000-0013
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: For use in root canal preparations by allowing irrigation\suction of irrigant fluid
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.

Z12110199INSTRUMENTS FOR DENTAL TREATMENT UNITS - 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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