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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

100333 — Class IIa MDR by Dr. Wittmann GmbH & Co.…

MD Atlas
Dr. Wittmann GmbH & Co. KG

EUDAMED last updated this device on Dec 20, 2022

100333

426065018ultracleanS4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Wittmann GmbH & Co. KG
UDI-DI code: 04260650180019
Reference / catalog number: 100333

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Manufacturer information

Organization name: Dr. Wittmann GmbH & Co. KG
SRN: DE-MF-000019842
Manufacturer status: Active

Critical warnings

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

CW164
Nur im Freien oder in gut belüfteten Räumen verwenden.
CW167
Schutzhandschuhe und Schutzbrille tragen.
CW397
EUDAMED did not publish a description for this code.
CW401
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW999
P310 Sofort GIFTINFORMATIONSZENTRUM/Arzt anrufen.
CW999
Alle im Zusammenhang mit dem Produkt aufgetretenen schwerwiegenden Vorkommnisse sind dem Hersteller (durch den lokalen Händler) und der zuständigen Behörde des Mitgliedsstaats zu melden.
CW009
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW159
Einatmen von Dampf vermeiden.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 1986	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260650180019
Basic UDI-DI: 426065018ultracleanS4
Reference / catalog number: 100333
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: ULTRA CLEAN ist eine Reinigungs- und Desinfektionslösung für alle wasserführenden Leitungen von Dental-Ultraschallprophylaxe-Geräten, für nicht invasive Produkte.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

D0502HYDROGEN PEROXIDE FOR DISINFECTION OF MEDICAL DEVICES

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

NIGHT CLEANER MAX426065018NCproGHOn 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.