UNISIS CORP.
2675-1 Nishikata, Koshigaya-shi,Saitama 343-0822,
Japan
24 July 2023
Confirmation Letter Reference: CLNB1639 - JP/YOK/8093
To whom it may concern,
Confirmation that the manufacturer has presented the evidence of a formal application andconclusion of written agreement in the framework of Regulation EU 2023/607 amending Regulations(EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices
and in vitro diagnostic medical devices.
This letter confirms that, DEKRA Certification B.V, a Notified Body (NB) designated against Regulation(EU) 2017/745 (MDR) and identified by the number 0344 on NANDO, has received a formal
application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed awritten agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR withthe following manufacturer
UNISIS CORP.
2675-1 Nishikata, Koshigaya-shi,
Saitama 343-0822,
Japan
SRN Number (if available): JP-MF-000026339
Authorized representative:
ADVENA LTD.
Tower Business Centre, 2nd FLR.,
Tower street, Swatar BKR 4013
MaltaThe devices covered by the formal application and the written agreement mentioned above areshown at the end of this letter.
In the case of devices covered by certificates issued under Directive 90/385/EEC (AIMDD) or Directive
93/42/EEC (MDD) that expired prior to the publication of the Regulation EU 2023/607 on 15th March
2023, this letter also confirms that:SGS Belgium NV

Certification and Business Enhancement Registered Office: Noorderlaan 87 BE-2030 Antwerpen t +32 (0)3 545 48 48 f +32 (0)3 545 48 49
Boulevard International/Internationalelaan 55D BE-1070 Brussels t+32 (0)2 556 00 40 f +32 (0)3 545 48 49 www.be.sgs.com

Member of the SGS GroupRPR Antwerpen VAT BE 0404 882 750 Belfius 550-3560000-93

••The manufactured provided evidence that a competent authority of a Member State had
granted a derogation/exemption from the applicable conformity assessment procedure inaccordance with Article 59(1) of MDR or Article 97(1) of the MDR by the 16th Mar 2023.
The certificates expired after 26th May 2021 by course of time and were valid at the date of
their expiry neither having been suspended nor withdrawn.

The transition timelines that apply to the devices covered by this letter, subject to themanufacturer’s continued compliance to the other conditions specified in Article 120.3 of MDR (asamended by EU 2023/607), are shown below:• 26th May 2026 for Class III custom-made implantable devices• 31st December 2027 for Class III devices and Class IIb implantable devices excluding Wellestablished technologies (WET - sutures, staples, dental fillings, dental braces, tooth crowns,screws, wedges, plates, wires, pins, clips and connectors)• 31st December 2028 for other Class IIb devices, Class IIa, Class I devices placed on the market
in sterile condition or have a measuring function• 31st December 2028 for devices not requiring the involvement of a notified body under MDD
but requiring it under MDR (e.g., class I devices that qualify as re-usable surgical instruments)
On behalf of the Notified Body SGS Belgium NV 1639,

Pp [Sean Kelly]
Virginie SILORET
Global Medical Device Certification Manager
Email: Virginie.siloret@sgs.com
Phone: +41 22 739 98 58

Devices covered by this letter:
Device name / BasicMDR DeviceUDI-DI
classification (asproposed by themanufacturer andverified at the preapplication stage)
Sterile single use
Class IIb
epidural anaesthesia

SGS Belgium NV

If the MDR device is a
substitute device,identification of thecorresponding
MDD/AIMDD device

MDD/AIMDD Certificate
Reference(s) of thedevices under MDR
application, and the NB
Identification

N/A

JP19/030582

Certification and Business Enhancement Registered Office: Noorderlaan 87 BE-2030 Antwerpen t +32 (0)3 545 48 48 f +32 (0)3 545 48 49
Boulevard International/Internationalelaan 55D BE-1070 Brussels t+32 (0)2 556 00 40 f +32 (0)3 545 48 49 www.be.sgs.com

Member of the SGS GroupRPR Antwerpen VAT BE 0404 882 750 Belfius 550-3560000-93

Device name / Basic
UDI-DIMDR Deviceclassification (asproposed by themanufacturer andverified at the preapplication stage)

If the MDR device is a
substitute device,identification of thecorresponding
MDD/AIMDD device

MDD/AIMDD Certificate
Reference(s) of thedevices under MDR
application, and the NB
Identification

Class III

N/A

JP19/030582
JP19/040523

Class III

N/A

JP19/030582
JP19/040524

Class IIa

N/A

JP19/030582

Class IIa

N/A

JP19/030582

Class IIa

N/A

JP19/030582

Class IIa

N/A

JP19/030582

Class Is

N/A

JP19/030582

kit / Basic UDI-DI;
45894024403MTY5S
Sterile single use
combined spinal
epidural anaesthesia
kit / Basic UDI-DI;
45894024402CSE2N
Sterile single use
spinal anaesthesia
needle / Basic UDI-DI;
45894024401SPI4W
Sterile and non-sterile
single use epiduralanaesthesia needle
and Sterile and nonsterile
single use neveblockade needle /Basic UDI-DI;
45894024404EPI3D
Sterile and non-sterile
single use introducer /Basic UDI-DI;
45894024405INT4Q
Sterile and non-sterile
single use biopsy
needle / Basic UDI-DI;
45894024406BPY4C
Sterile single use
injection needle /Basic UDI-DI;
45894024407MIC49
Sterile single use lossof resistance syringe /Basic UDI-DI;

SGS Belgium NV

Certification and Business Enhancement Registered Office: Noorderlaan 87 BE-2030 Antwerpen t +32 (0)3 545 48 48 f +32 (0)3 545 48 49
Boulevard International/Internationalelaan 55D BE-1070 Brussels t+32 (0)2 556 00 40 f +32 (0)3 545 48 49 www.be.sgs.com

Member of the SGS GroupRPR Antwerpen VAT BE 0404 882 750 Belfius 550-3560000-93

Device name / BasicUDI-DIMDR Deviceclassification (asproposed by themanufacturer andverified at the preapplication stage)

If the MDR device is a
substitute device,identification of thecorresponding
MDD/AIMDD device

MDD/AIMDD Certificate
Reference(s) of thedevices under MDR
application, and the NB
Identification

45894024410LOR4E
Confirmation Letter Revision History
Date
NB internal reference
traceable to eachversion of the letter2023/07/24
Version 1

SGS Belgium NVAction

Initial issue

Certification and Business Enhancement Registered Office: Noorderlaan 87 BE-2030 Antwerpen t +32 (0)3 545 48 48 f +32 (0)3 545 48 49
Boulevard International/Internationalelaan 55D BE-1070 Brussels t+32 (0)2 556 00 40 f +32 (0)3 545 48 49 www.be.sgs.com

Member of the SGS GroupRPR Antwerpen VAT BE 0404 882 750 Belfius 550-3560000-93