Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

635228 — Class I MDD by Hager & Werken GmbH &…

MD Atlas
Hager & Werken GmbH & Co. KG

EUDAMED last updated this device on Apr 1, 2026

635228

B-04099637010175

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hager & Werken GmbH & Co. KG
UDI-DI code: 04099637010175
Reference / catalog number: 635228

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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

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.

Critical warnings

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

CW008
Die Verwendung des Nasensprays durch mehr als eine Person kann zur Verbreitung einer Infektion führen. Wir empfehlen, den Sprühkopf nach jeder Anwendung zu reinigen und wieder zu verschließen.
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: 04099637010175
Basic UDI-DI: B-04099637010175
Reference / catalog number: 635228
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