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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

TW1413 — Class I MDR by Jespira GmbH

MD Atlas
Jespira GmbH

EUDAMED last updated this device on Jun 3, 2025

TW1413

426243931AJN111XF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Jespira GmbH
UDI-DI code: 04262439310006
Reference / catalog number: TW1413

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Manufacturer information

Organization name: Jespira GmbH
SRN: DE-MF-000044965
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jun 3, 2025	Still on market
Austria	Jun 3, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262439310006
Basic UDI-DI: 426243931AJN111XF
Reference / catalog number: TW1413
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 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)

R0599RESPIRATORY DEVICES, SUCTION AND DILATION SYSTEMS - 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

This device is not currently linked to any other device.

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.