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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

SPIRO — Class I MDR by Fogless International AB

MD Atlas
Fogless International AB

EUDAMED last updated this device on Nov 10, 2023

SPIRO

73500612300779

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fogless International AB
UDI-DI code: 17350061230343
Reference / catalog number: 730-2K

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View device family (Basic UDI)

Manufacturer information

Organization name: Fogless International AB
SRN: SE-MF-000001616
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW262
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Sweden; available across 1 country total.

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

Device identification

Trade name: SPIRO
UDI-DI code: 17350061230343
Basic UDI-DI: 73500612300779
Reference / catalog number: 730-2K
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: Shower Protector for Speaking Valve
Additional information URL: https://www.fogless.se/eifu
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

R900680PHONATION VALVES - ACCESSORIES

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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Related devices

SPIRO7350061230026XOn the market SPIRO73500612300677On the market SPIRO73500612300677On the market SPIRO73500612300677On 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.