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Organization name
UDI-DI code
Reference / catalog number

SpiroSafe Disposable Flow… — Class IIa MDD by Medikro Oy

MD Atlas
Medikro Oy

EUDAMED last updated this device on May 15, 2024

SpiroSafe Disposable Flow Transducers

B-M9242-B-100FL

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Medikro Oy
UDI-DI code: D-M9242-B-100FL
Reference / catalog number: M9242-B-100

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Manufacturer information

Organization name: Medikro Oy
SRN: FI-MF-000011841
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
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 Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: SpiroSafe Disposable Flow Transducers
UDI-DI code: D-M9242-B-100FL
Basic UDI-DI: B-M9242-B-100FL
Reference / catalog number: M9242-B-100
Issuing entity: EUDAMED

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)

Z12150185SPIROMETRY INSTRUMENTS - CONSUMABLES

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

Disposable Flow TransducerB-M9256-WA-SP-25YPOn the market Disposable Flow TransducerB-M9256-MM-100PEOn the market Disposable Flow TransducerB-M9256-MM-SP-1003TOn the market Disposable Flow TransducerB-M9242-WA-25SUOn the market Disposable Flow TransducerB-M9256-WA-SP-1003VOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1056-876-25Supplemented
Quality management systemNotified body: 0537Expiry: May 9, 2030