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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

1271 — Class I MDR by Pearl Technology AG

MD Atlas
Pearl Technology AG

EUDAMED last updated this device on Apr 4, 2024

1271

764017806GantryCoverHT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pearl Technology AG
UDI-DI code: 07640178061484
Reference / catalog number: 1271

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Manufacturer information

Organization name: Pearl Technology AG
SRN: CH-MF-000018100
Manufacturer status: Active

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.

Market distribution

Primary placement in Malta; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07640178061484
Basic UDI-DI: 764017806GantryCoverHT
Reference / catalog number: 1271
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: Reusable hygienic device shield for CT devices during invasive and non-invasive procedures to protect the CT device from penetrating fluids. Covers the lower half of the CT gantry. May only be used by medical personnel. Non-sterile and not to be used in the sterile field.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1960 MU50
1080 MU50

EMDN nomenclature code(s)

Z11030699COMPUTED TOMOGRAPHS (CT) - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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