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Organization name
UDI-DI code
Reference / catalog number

Isotonic saline nasal spray — Class I MDD by Ursatec GmbH

MD Atlas
Ursatec GmbH

EUDAMED last updated this device on Apr 24, 2026

Isotonic saline nasal spray

B-6601015XU

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Ursatec GmbH
UDI-DI code: D-6601015XU
Reference / catalog number: 6601015

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Manufacturer information

Organization name: Ursatec GmbH
SRN: DE-MF-000005353
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 28, 2021	Dec 31, 2028

Device identification

Trade name: Isotonic saline nasal spray
UDI-DI code: D-6601015XU
Basic UDI-DI: B-6601015XU
Reference / catalog number: 6601015
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: 20 MU03

EMDN nomenclature code(s)

Q030103NASAL IRRIGATION SOLUTIONS

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

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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.