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

10000700 — 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

10000700

426074131-GINGIVA-OCO-73

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: 04260741310134
Reference / catalog number: 10000700

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: 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: 04260741310134
Basic UDI-DI: 426074131-GINGIVA-OCO-73
Reference / catalog number: 10000700
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: Der flüssige Kofferdam. GINGIVA-SICCATIV dient zum Trockenhalten des Zahnfleischsaumes und des Zahnstumpfes vor dem Einzementieren von Kronen und Brücken, zur Verhinderung störender Salivation.
Additional information URL: https://www.oco-praeparate.de/de/p/gingiva_siccativ/
Clinical sizes: 5 MU48

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

Related devices

10001100 426074131-CALXYL-OCO-B9On the market 10000100426074131-CALXYL-OCO-B9On the market 10004100426074131-CALXYL-OCO-B9On the market 10000200426074131-CALXYL-OCO-B9On the market 10001200426074131-CALXYL-OCO-B9On 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.