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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

PU901 — Class I MDR by Knop Elektronik A/S

MD Atlas
Knop Elektronik A/S

EUDAMED last updated this device on Jul 8, 2022

PU901

574400285PU9018B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Knop Elektronik A/S
UDI-DI code: 05744002850403
Reference / catalog number: PU901

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View device family (Basic UDI)

Manufacturer information

Organization name: Knop Elektronik A/S
SRN: DK-MF-000025631
Manufacturer status: Active

Related devices

CT901574400285CT9013MOn the market CT901BED574400285CT9013MOn the market KK100574400285KK9014EOn the market KK901574400285KK9014EOn the market KK901AP574400285KK9014EOn 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.

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Market distribution

Primary placement in Denmark; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05744002850403
Basic UDI-DI: 574400285PU9018B
Reference / catalog number: PU901
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: Personal transmitter for a patient/client with special needs for calling assistance. Patient/client must blow into the product to activate the transmitter.
Additional information URL: https://www.knop.dk/
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)05744002850403

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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.

Y214299DEVICES FOR INTERPERSONAL COMUNICATION - 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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