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Organization name
UDI-DI code
Reference / catalog number

04104480000270 — Class IIa MDR by Engelhard Arzneimittel…

MD Atlas
Engelhard Arzneimittel GmbH & Co. KG

EUDAMED last updated this device on Feb 23, 2026

04104480000270

4104480Nisita_OintmentXN

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Engelhard Arzneimittel GmbH & Co. KG
UDI-DI code: 04104480000270
Reference / catalog number: 04104480000270

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Manufacturer information

Organization name: Engelhard Arzneimittel GmbH & Co. KG
SRN: DE-MF-000025566
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Luxembourg		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04104480000270
Basic UDI-DI: 4104480Nisita_OintmentXN
Reference / catalog number: 04104480000270
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

This device is not currently linked to any other device.

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.