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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

AIRSPEN01 — Class I MDR by AIRMAX BV

MD Atlas
AIRMAX BV

EUDAMED last updated this device on Oct 18, 2023

AIRSPEN01

871766257P911JG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AIRMAX BV
UDI-DI code: 08717662570803
Reference / catalog number: AIRSPEN01

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View device family (Basic UDI)

Manufacturer information

Organization name: AIRMAX BV
SRN: NL-MF-000003016
Manufacturer status: Active

Related devices

AIRSPNL04871766257P911JGOn the market AIRSPNL02871766257P911JGOn the market AIRSPNL03871766257P911JGOn the market AIRCLEN04871766257P911JGOn the market AIRCLEN03871766257P911JGOn 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.

Critical warnings

2 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.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08717662570803
Basic UDI-DI: 871766257P911JG
Reference / catalog number: AIRSPEN01
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: 2
Additional product description: 2x Small (ENG)
Additional information URL: https://www.airmax.nu/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08717662570803

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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