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Organization name
UDI-DI code
Reference / catalog number

GSAFE2018 — Class IIa MDD by VitalAire GmbH

MD Atlas
VitalAire GmbH

EUDAMED last updated this device on Oct 15, 2024

GSAFE2018

B-04260159810264

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: VitalAire GmbH
UDI-DI code: 04260159810264
Reference / catalog number: GSAFE2018

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Manufacturer information

Organization name: VitalAire GmbH
SRN: DE-MF-000005323
Manufacturer status: Active

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: 04260159810264
Basic UDI-DI: B-04260159810264
Reference / catalog number: GSAFE2018
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

A01010301NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS

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

GSAFE1915B-04260159810219On the market GSAFE1918B-04260159810226On the market GSAFE1920B-04260159810233On the market GSAFE1925B-04260159810240On the market GSAFE2015B-04260159810257On 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.