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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

Ear Spray with Propionate — Class I MDD by PROPONENT Biotech AG

MD Atlas
PROPONENT Biotech AG

EUDAMED last updated this device on May 25, 2026

Ear Spray with Propionate

B-++G565PSESJG

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PROPONENT Biotech AG
UDI-DI code: ++G565PSESJG
Reference / catalog number: PSES01

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Manufacturer information

Organization name: PROPONENT Biotech AG
SRN: CH-MF-000036207
Manufacturer status: Active

Critical warnings

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

CW999
Precautions: Use PSES as described in these instructions for use. Should not be used by pregnant and breastfeeding women due to general precautions. With proper use of PSES, there are no other warnings or precautions. Contraindications: PSES must not be used in case of hypersensitivity to sodium propionate or any of the other ingredients. Interactions with other medicinal products: There are no known interactions.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Ear Spray with Propionate
UDI-DI code: ++G565PSESJG
Basic UDI-DI: B-++G565PSESJG
Reference / catalog number: PSES01
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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

++G565PSESJG

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

Q03040299EAR IRRIGATION 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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Related devices

Mouth & Throat Spray with PropionateB-++G565PSTSKVOn the market Nasal Spray with PropionateB-++G565PSNSKBOn 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.