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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

Baldus Double Masks (Single use),… — Class IIa MDR

MD Atlas
Baldus Sedation GmbH & Co. KG

EUDAMED last updated this device on May 12, 2026

Baldus Double Masks (Single use), Adult, Scent Happy Apple

426063579MASKCG

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Baldus Sedation GmbH & Co. KG
UDI-DI code: 04260635790547
Reference / catalog number: 16030-AA

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Manufacturer information

Organization name: Baldus Sedation GmbH & Co. KG
SRN: DE-MF-000006223
Manufacturer status: Active

Critical warnings

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

CW010
Warnhinweise und Kontraindikationen sind in der Gebrauchsanweisung beschrieben.

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: Baldus Double Masks (Single use), Adult, Scent Happy Apple
UDI-DI code: 04260635790547
Basic UDI-DI: 426063579MASKCG
Reference / catalog number: 16030-AA
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 12
Additional product description: The Baldus Single Use Double Nasal Mask Adult "Happy Apple" is a single-use double nasal mask made of thermoplastic elastomer (TPE) and is used as part of the Baldus Double Nasal Mask Scavenger System. It is intended to administer a gas mixture of medical oxygen and medical nitrous oxide to the patient for inhalation sedation, while simultaneously extracting the exhaled gas via the connected suction system. The product is latex-free and intended for single use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R030199RESPIRATORY MASKS - 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

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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.