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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

2015-30 — Class I MDR by Opitek International

MD Atlas
Opitek International

EUDAMED last updated this device on Dec 6, 2023

2015-30

0571483400100TG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Opitek International
UDI-DI code: 05714834001250
Reference / catalog number: 2015-30

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View device family (Basic UDI)

Manufacturer information

Organization name: Opitek International
SRN: DK-MF-000001594
Manufacturer status: Active

Related devices

2015-200571483400100TGOn the market 2015-100571483400100TGOn the market 1900-010571483400100TGOn the market 1915-2000571483400100TGOn the market 1915-1000571483400100TGOn the market

Critical warnings

No critical warnings reported for this device.

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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: 05714834001250
Basic UDI-DI: 0571483400100TG
Reference / catalog number: 2015-30
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: https://opitek-international.dk/hip-fix/
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)05714834001250

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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.

Z12011299PATIENT POSITIONING INSTRUMENTS – 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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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.