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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

635227 - (630185 miradent XYLIMED… — Class I MDD

MD Atlas
Hager & Werken GmbH & Co. KG

EUDAMED last updated this device on Apr 1, 2026

635227 - (630185 miradent XYLIMED NASENTROPFEN KINDER 22 ml

B-04099637006833

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hager & Werken GmbH & Co. KG
UDI-DI code: 04099637006833
Reference / catalog number: 635227 - (630185 miradent XYLIMED NASENTROPFEN KINDER 22 ml

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Manufacturer information

Organization name: Hager & Werken GmbH & Co. KG
SRN: DE-MF-000004938
Manufacturer status: Active

Related devices

101002409963700010033On the market 101003409963700010033On the market 101042409963700010033On the market 101009409963700010033On the market 101004409963700010033On the market

Critical warnings

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

CW008
Die Verwendung der Tropfen durch mehr als ein Kind kann zur Verbreitung einer Infektion führen. Zusätzlich empfehlen wir, die Spritzdüse nach jeder Anwendung zu.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 3 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: 04099637006833
Basic UDI-DI: B-04099637006833
Reference / catalog number: 635227 - (630185 miradent XYLIMED NASENTROPFEN KINDER 22 ml
Issuing entity: GS1

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)

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

Certificates

Certificate health across this manufacturer's portfolio.

HZ 1011605-1Issued
Quality management systemNotified body: 0197Expiry: May 21, 2031