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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

octenisan md gel nasal — Class IIa MDR by Schülke & Mayr GmbH

MD Atlas
Schülke & Mayr GmbH

EUDAMED last updated this device on May 22, 2026

octenisan md gel nasal

4032651BSC00000033A9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Schülke & Mayr GmbH
UDI-DI code: 04032651977604
Reference / catalog number: 70002281

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View device family (Basic UDI)

Manufacturer information

Organization name: Schülke & Mayr GmbH
SRN: DE-MF-000005701
Manufacturer status: Active

Critical warnings

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

CW999
Should not be used with known or suspected allergy to one of the ingredients. In case of doubt consult a doctor
CW999
Not suitable for children under 1 year.
CW999
do not use on hyaline cartilage, eyes, ears
CW999
Do not insert too deep in the nose.
CW999
Do not use for infusion or injection
CW999
do not swallow

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Market distribution

Primary placement in Germany; available across 2 countries total.

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

Device identification

Trade name: octenisan md gel nasal
UDI-DI code: 04032651977604
Basic UDI-DI: 4032651BSC00000033A9
Reference / catalog number: 70002281
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04032651977604

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q030199NASOPHARYNGEAL 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

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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.