Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SF-10-300-025-0064 — Class IIa MDR by ReDent Nova GmbH

MD Atlas
ReDent Nova GmbH

EUDAMED last updated this device on Nov 5, 2025

SF-10-300-025-0064

426235751SAF0012C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ReDent Nova GmbH
UDI-DI code: 14262357510073
Reference / catalog number: SF-10-300-025-0064

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 14262357510073
Basic UDI-DI: 426235751SAF0012C
Reference / catalog number: SF-10-300-025-0064
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: Mechanically operated endodontic file to be used for cleaning and shaping of root canals
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 3 MU50
25 MU50

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.

Q010507ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE

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

Become a partner of MD Atlas