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

1272 — Class I MDR by Pearl Technology AG

MD Atlas
Pearl Technology AG

EUDAMED last updated this device on Apr 4, 2024

1272

764017806RollHolder2B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pearl Technology AG
UDI-DI code: 07640178061491
Reference / catalog number: 1272

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: 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: 07640178061491
Basic UDI-DI: 764017806RollHolder2B
Reference / catalog number: 1272
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 holder for CT paper rolls during invasive and non-invasive procedures. 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: 350 MU50
650 MU50
18 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

Related devices

1302-A764017806GantryCoverHTOn the market 1304-A764017806GantryCoverHTOn the market 1271764017806GantryCoverHTOn the market 1303-A764017806GantryCoverHTOn the market 1231-A764017806GantryCoverHTOn the market