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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

Bittium APV20 — Class IIa MDR by Bittium Biosignals Oy

MD Atlas
Bittium Biosignals Oy

EUDAMED last updated this device on Sep 21, 2022

Bittium APV20

643003522SleepDisordersT7

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bittium Biosignals Oy
UDI-DI code: 06430035220526
Reference / catalog number: 9404613

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Manufacturer information

Organization name: Bittium Biosignals Oy
SRN: FI-MF-000013983
Manufacturer status: Active

Related devices

S0000022661643003522SuiteCYAOn the market 9530433643003522SuiteMYWOn the market S0000023073643003522BittiumPhysiorFBOn the market 9404612643003522SleepDisordersT7On the market Bittium Respiro Analyst643003522SleepAnalysisFCOn 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

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement		Still on market
Sweden		Still on market

Device identification

Trade name: Bittium APV20
UDI-DI code: 06430035220526
Basic UDI-DI: 643003522SleepDisordersT7
Reference / catalog number: 9404613
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

V0399MEASUREMENT DEVICES - 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