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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

Ventilution — Class IIa MDR by Gründler GmbH

MD Atlas
Gründler GmbH

EUDAMED last updated this device on Apr 25, 2023

Ventilution

426237137000951BQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Gründler GmbH
UDI-DI code: 04262371370007
Reference / catalog number: 000176

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Manufacturer information

Organization name: Gründler GmbH
SRN: DE-MF-000025923
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW258
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 25, 2023	Still on market

Device identification

Trade name: Ventilution
UDI-DI code: 04262371370007
Basic UDI-DI: 426237137000951BQ
Reference / catalog number: 000176
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: 1
Additional product description: —
Additional information URL: https://www.ggmed.de/
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

Related devices

Ventilution426237137000952BSOn 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.