Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

Duomix II 230 V~, 50/60 Hz — Class I MDR by Renfert GmbH

MD Atlas
Renfert GmbH

EUDAMED last updated this device on Jul 27, 2023

Duomix II 230 V~, 50/60 Hz

++J0096000ZN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Renfert GmbH
UDI-DI code: +J00927610000000
Reference / catalog number: 2761000000

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?

Manufacturer information

Organization name: Renfert GmbH
SRN: DE-MF-000005448
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 5, 2021	Jan 27, 2024

Device identification

Trade name: Duomix II 230 V~, 50/60 Hz
UDI-DI code: +J00927610000000
Basic UDI-DI: ++J0096000ZN
Reference / catalog number: 2761000000
Issuing entity: HIBCC

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: Dental impression material mixer, Dentsply Sirona brand
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010207DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

2222100++J0092200Z4On the market 2232100++J0092200Z4On the market Dynamix ® speed 2++J0096000ZNOn the market help:ex discolor f++J00967002UOn the market 67000100++J00967002UOn 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.