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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

16009-60 — Class IIb MDR by Baldus Sedation GmbH &…

MD Atlas
Baldus Sedation GmbH & Co. KG

EUDAMED last updated this device on May 12, 2026

16009-60

426063579ANALOG9J

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Baldus Sedation GmbH & Co. KG
UDI-DI code: 04260635790066
Reference / catalog number: 16009-60

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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: not provided
UDI-DI code: 04260635790066
Basic UDI-DI: 426063579ANALOG9J
Reference / catalog number: 16009-60
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The Baldus Analog 60% is an analogue oxygen-nitrous oxide mixer used to administer a gas mixture of medical oxygen and medical nitrous oxide to patients. The device is intended for light sedation and analgesia of patients in medical and dental offices by trained medical professionals. The maximum nitrous oxide concentration is 60%.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R9099RESPIRATORY AND ANAESTHESIA 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

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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.