MDR-Eudamed - Search Devices and System or Procedure Packs_UDI

7/27/22, 1:03 PM MDR-Eudamed - Search Devices and System or Procedure Packs
EUDAMED
(https://ec.europa.eu)
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CURRENT ACTOR: Manufacturer, IN-MF-000026224, Telerad TechTelerad Tech Private

Limited [India] Notifications
UDI-DI +B228INTELEPACS0
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Manufacturer
information
Basic UDI-DI
details
UDI-DI details
Market information
Clinical 
Investigation(s)
https://webgate.ec.europa.eu/eudamed/secure#/devices/search/view/2259292e-063c-4417-a93c-bcab19ffd695 1/10
Certificate
information
Manufacturer information
Organisation name: Intelerad Medical Systems Incorporated
Actor ID/SRN: CA-MF-000011834
Address: 800 Boul, De Maisonneuve East, 12th Floor Montreal
Telephone number: +1 514 931 4653
Email: regulatory@intelerad.com
Authorised Representative
Organisation name: Emergo Europe B.V.
Eudamed Actor ID: NL-AR-000000116
Address: 20 Prinsessegracht Den Haag
Telephone number: 15126007609
Email: lst.aus.euauthrep@ul.com
Basic UDI-DI details

Version 1 [Current] Last update date:  2022-07-08

Basic UDI-DI identification
Applicable regulation: MDR (REGULATION (EU) 2017/745 on medical devices)
Basic UDI-DI code: ++B228INTELEPACSSC

Issuing Entity: HIBCC
Is it a System or Procedure Pack which is a Device in itself? No

Special device type: Software
Risk class: Class IIa
Implantable: No
Measuring function: Yes
Reusable surgical No
instruments:
Active device: Yes
Device intended to No
administer and/or remove
medicinal product:
Device model applicable: Yes
Device model: 5-X-X


Name: IntelePACS
Tissues and cells

Tissues and cells
Presence of human No
tissues or cells, or their
derivatives:
Presence of animal No
tissues or cells, or their
derivatives:
Information on substances
Presence of a substance No
which, if used separately,
may be considered to be
a medicinal product:
Presence of a substance No
which, if used separately,
a medicinal product
derived from human
blood or human plasma:
List of UDI-DIs for the Basic UDI-DI 
UDI-DI details
UDI-DI code: +B228INTELEPACS0
Issuing Entity: HIBCC
UDI-DI from another entity

UDI-DI from another No
entity (secondary)
applicable:
Selected nomenclature codes
Code Z110603 PICTURE ARCHIVING AND

COMMUNICATION SYSTEMS
Trade name
Trade name applicable: Yes
Trade name: IntelePACS [EN]
Reference/Catalogue N/A
number:

Is the device directly marked?
Is the device directly No
marked?:
Quantity of device: 1
Type of UDI-PI
Lot or Batch number: Yes
Software identification: -
Additional product "IntelePACS™ is comprised of software modules that

description: provide image capture, storage, distribution, enhancement,
manipulation, and networking of medical images at
distributed locations. In cases where DICOM images are
not directly available to IntelePACS™, the system can
acquire medical images using a DICOM image gateway,
which generates DICOM-type files. For example, film
digitizers obtain images from original film and convert them
to meet DICOM standards. Stored files are transmitted
using a network and can be viewed or manipulated using
InteleViewer viewing software. [EN]
URL for additional https://inteleradprod.service-now.com/csm?

information (as electronic id=kb_search&kb_category=053536cc1b79a410a82ba715e
instructions for use): c4bcb90
UDI-DI status: On the EU market


UDI-DI characteristics
Clinical size
Clinical size applicable: No
Labelled as single use

Labelled as single use: No
Maximum number of No
reuses applicable:
Maximum number of -
reuses:
Need for sterilisation No

before use:
Device labelled as sterile: No
Containing latex: No
CMR/Endocrine disruptor

Labelled for presence of No
Carcinogenic, Mutagenic
and toxic to
Reproduction (CMR)
substances of category
1A or 1B:
Labelled for presence of No

substance(s) with
endocrine-disrupting
properties:
Storage/handling conditions
Storage/handling No
conditions, if applicable:
Critical warnings or contra-indications

Critical warnings or No
contra-indications, if
applicable:
Reprocessed single use No

device: 
Intended purpose other No

than medical (Annex
XVI):
Information on substances
Presence of a substance
which, if used separately, Not applicable
a medicinal product:
Presence of a substance
which, if used separately, Not applicable
a medicinal product
derived from human
blood or human plasma:
Market information
Member State of the Ireland

placing on the EU market
of the Device:
Member States where CountryFrom To


device is or is to be made Ireland 2006-06-06 -
available on the market:
Clinical Investigation(s)
Clinical Investigation
Clinical Investigation, if No
applicable:
Certificate information

MDR-Eudamed - Search Devices and System or Procedure Packs_UDI

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7/27/22, 1:03 PM MDR-Eudamed - Search Devices and System or Procedure Packs

CURRENT ACTOR: Manufacturer, IN-MF-000026224, Telerad TechTelerad Tech Private

Basic UDI-DI details

Basic UDI-DI code: ++B228INTELEPACSSC

Is it a System or Procedure Pack which is a Device in itself? No

Risk class: Class IIa

Measuring function: Yes

Active device: Yes

Device model applicable: Yes

Device model: 5-X-X

Tissues and cells

List of UDI-DIs for the Basic UDI-DI 

UDI-DI code: +B228INTELEPACS0

Issuing Entity: HIBCC

UDI-DI from another entity

Selected nomenclature codes

Code Z110603 PICTURE ARCHIVING AND

Trade name: IntelePACS [EN]

Additional product "IntelePACS™ is comprised of software modules that

URL for additional https://inteleradprod.service-now.com/csm?

UDI-DI status: On the EU market

Labelled as single use

Need for sterilisation No

Device labelled as sterile: No

Labelled for presence of No

Critical warnings or contra-indications

Reprocessed single use No

Intended purpose other No

Member State of the Ireland

Member States where CountryFrom To

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