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Organization name
UDI-DI code
Reference / catalog number

Ectoin® Sicca Nasal Spray — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 7, 2026

Ectoin® Sicca Nasal Spray

B-DE-MF-000006543-30093SZ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-30093SZ
Reference / catalog number: 30093

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Manufacturer information

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

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Critical warnings

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

CW999
•Product should not be used after nasal operations or injuries of the nose.• Product should not be used in the 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.•To ensure safe hygiene,each nasal spray bottle should only be used by one person.•Do not use for more than 6 weeks after opening.•Product should be kept out of reach of children.

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: Ectoin® Sicca Nasal Spray
UDI-DI code: D-DE-MF-000006543-30093SZ
Basic UDI-DI: B-DE-MF-000006543-30093SZ
Reference / catalog number: 30093
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

Certificates

Certificate health across this manufacturer's portfolio.

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