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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

PT 0344 Orthopedic semi-rigid… — Class I MDR

MD Atlas
SIGVARIS SPÓŁKA AKCYJNA

EUDAMED last updated this device on Feb 6, 2025

PT 0344 Orthopedic semi-rigid cervical collar 2 in 1 YOUNG

5906699PT0344ZH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SIGVARIS SPÓŁKA AKCYJNA
UDI-DI code: 05906699077918
Reference / catalog number: 359556

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Manufacturer information

Organization name: SIGVARIS SPÓŁKA AKCYJNA
SRN: PL-MF-000004824
Manufacturer status: —

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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 Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Feb 6, 2025	Still on market

Device identification

Trade name: PT 0344 Orthopedic semi-rigid cervical collar 2 in 1 YOUNG
UDI-DI code: 05906699077918
Basic UDI-DI: 5906699PT0344ZH
Reference / catalog number: 359556
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: colour: pink; height: 7 cm; size: II
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y060312CERVICAL SPINE 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

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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.