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Organization name
UDI-DI code
Reference / catalog number

2% medEctoin Rhinitis Nasal Spray — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Dec 1, 2025

2% medEctoin Rhinitis Nasal Spray

B-DE-MF-000006543-38109UF

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38109UF
Reference / catalog number: 38109

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Manufacturer information

Organization name: bitop AG
SRN: DE-MF-000006543
Manufacturer status: Active

Critical warnings

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

CW999
Warnings and precautions • The Product should not be used in case of hypersensitivity to Ectoin® or any of the other ingredients of the nasal spray. • If allergic reactions occur, the use of the Product must be discontinued immediately. • Do not use if the device is damaged or punctured. • To ensure safe hygiene, each nasal spray bottle should only be used by one person. • Do not use for more than 3 months after opening. • The Product should be kept out of reach of children. Additional information If the Product is applied within its intended use, there is no evidence for a particular risk during pregnancy or breast-feeding. The Product is suitable for children. Children 10 years of age and younger and patients unable to use the Product on their own should be assisted during the application of the Product.

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: 2% medEctoin Rhinitis Nasal Spray
UDI-DI code: D-DE-MF-000006543-38109UF
Basic UDI-DI: B-DE-MF-000006543-38109UF
Reference / catalog number: 38109
Issuing entity: EUDAMED

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.

EMDN nomenclature code(s)

Q0399ENT 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

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Certificates

Certificate health across this manufacturer's portfolio.

HZ 1342003-1Supplemented
Quality management systemNotified body: 0197Expiry: Feb 26, 2029