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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

00012047 — Class IIb MDR by Dr. August Wolff GmbH &…

MD Atlas
Dr. August Wolff GmbH & Co. KG Arzneimittel

EUDAMED last updated this device on Apr 22, 2026

00012047

404888212047BR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. August Wolff GmbH & Co. KG Arzneimittel
UDI-DI code: 04048882120474
Reference / catalog number: 00012047

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Manufacturer information

Organization name: Dr. August Wolff GmbH & Co. KG Arzneimittel
SRN: DE-MF-000005943
Manufacturer status: Active

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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.

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW999
Nicht anwenden bei Überempfindlichkeit gegenüber einem der Bestandteile.
CW999
Nicht gleichzeitig mit Kondomen oder Diaphragmen aus Latex, Polyisopren oder Polyurethan anwenden (Reißgefahr).

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04048882120474
Basic UDI-DI: 404888212047BR
Reference / catalog number: 00012047
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 50 g gel. Language: German
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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