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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

Arctique — Class I MDR by POLAAR

MD Atlas
POLAAR

EUDAMED last updated this device on Apr 27, 2022

Arctique

3770026739POI14K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLAAR
UDI-DI code: 03770026739051
Reference / catalog number: POI1

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Manufacturer information

Organization name: POLAAR
SRN: FR-MF-000021372
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW030
EUDAMED did not publish a description for this code.
CW022
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW277
EUDAMED did not publish a description for this code.
CW305
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: Arctique
UDI-DI code: 03770026739051
Basic UDI-DI: 3770026739POI14K
Reference / catalog number: POI1
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060613WRIST-HAND-FINGERS ORTHOSES

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

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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.