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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

10000800 — Class I MDR by OCO-Präparate…

MD Atlas
OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH

EUDAMED last updated this device on Dec 15, 2022

10000800

426074131-ZAHNHALS-OCO-P3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH
UDI-DI code: 04260741310127
Reference / catalog number: 10000800

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Manufacturer information

Organization name: OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH
SRN: DE-MF-000012362
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Note the patient's allergy to one of the ingredients

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04260741310127
Basic UDI-DI: 426074131-ZAHNHALS-OCO-P3
Reference / catalog number: 10000800
Issuing entity: GS1

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: Indikationen: - Dentinhyperaesthesie durch Abnutzung,Abschürfung, Abschleifen, Frakturflächen und Initialkaries. Eine milde Ätzpaste, die eine nachhaltige Desensibilisierung der empfindlichen Zahnhälse erreicht. Die Feinheit der Paste ermöglicht ihre mühelose Verarbeitung auf der korrodierten Stelle. Das Eindringen bis in die feinsten Dentinkanälchen erreicht einen nachhaltigen Abschluß. Da die Paste keine Verfärbung hervorruft, ist ihre Verwendung im Frontzahnbereich möglich.
Additional information URL: https://www.oco-praeparate.de/de/p/zahnhalspaste/
Clinical sizes: 10 MU24

EMDN nomenclature code(s)

Q01010399DENTAL MEDICATION DEVICES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
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.