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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

Dynamix ® speed 2 — Class I MDR by Renfert GmbH

MD Atlas
Renfert GmbH

EUDAMED last updated this device on Jul 27, 2023

Dynamix ® speed 2

++J0096000ZN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Renfert GmbH
UDI-DI code: +J00925620000000
Reference / catalog number: 2562000000

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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: Dynamix ® speed 2
UDI-DI code: +J00925620000000
Basic UDI-DI: ++J0096000ZN
Reference / catalog number: 2562000000
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, Kulzer 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
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Software identification

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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.