SPIRO

Organization name

Fogless International AB

SRN

SE-MF-000001616

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW262

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 11 countries total.

Trade name

SPIRO

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

27350061230081

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-27350061230081

Reference / catalog number

710-2K

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Speaking Valve with oxygen nipple, 2 pcs per carton

Additional information URL

https://www.fogless.se/eifu

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• R90060202PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.