Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Himalaya — Class I MDR by POLAAR

MD Atlas
POLAAR

EUDAMED last updated this device on Apr 27, 2022

Himalaya

3770026739PIE139

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLAAR
UDI-DI code: 03770026739068
Reference / catalog number: PIE1

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Critical warnings

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

CW030
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.
CW010
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.

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: Himalaya
UDI-DI code: 03770026739068
Basic UDI-DI: 3770026739PIE139
Reference / catalog number: PIE1
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)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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

Alaska3770026739GEN1ZEOn the market Arctique3770026739POI14KOn the market Baltique3770026739HAN1YZOn the market Boréal3770026739GEN2ZGOn the market Everest3770026739POI24MOn 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.