CERTIFICATE O
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UKAF CERT
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Manufactured by
M/S. MARK ENTERPRISES
Address : FACTORY ADDRESS: SHED NO.1, PLOT NO. 93/2, STREET NO.17,MIDC,
SATPUR, NASHIK-422007, MAHARASHTRA, INDIA.
Product : Medical Products (AS PER ANNEXURE)
This certificate is
The certification body has performed an audit of the above product quality system covering the design, manufacture and final
inspection of certified product. The quality system has been assessed, approved and is subject to continuous surveillance according
of Medical Device Regulation (EU) 2017/745 Directive.
This certificate issued under the following conditions:
1. It applies only to the quality system maintained in the manufacturing of above referenced models and it does not substitute the
design or type examination procedures, if requested
2. The certificate remains valid until the manufacturing conditions or the quality system are changed
3. The certificate validity is conditioned by positive results of surveillance audits
4. After fulfilling relevant EEC legislation, the manufacturer shall affix to each device, of the referenced models The CE mark as
shown above can be used under the responsibility of the manufacturer after completion of an EEC Declaration of conformity and
compliance with all relevant EEC Directives. The statement is based on a single evaluation of one sample of above mentioned
product. not imply an assessment of the whole production.
Date of Initial Registration : 25-01-2024
Certificate No.: IQC/CEP4555641/24 Re Issue Date : 18-09-2024
1st Surveillance audit Due on : 24-01-2025
2nd Surveillance audit Due on : 24-01-2026
Date of Expiry : 24-01-2027
Authorised Signatory
UKAF CERT Limited
130 Thessaly Rd, Nine Elms,
London SW85EJ, UK
Email: info@[Link]
Website: [Link]
Accredited by United Kingdom Accreditation Forum Certification Limited (UKAF)
130 Thessaly Rd, Nine Elms, London SW85EJ, United Kingdom
The Approval is subject to the company maintaining its system to the required standards, which will be monitored by
UKAF CERT Limited. The Certificate remains the property of UKAF CERT Limited and must be returned on request.
To check the Validity of this certificate please visit on [Link]
CERTIFICATE O
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This is to certify that of
ANNEXURE-1
ANNEXURE TO CERTIFICATE NO : IQC/CEP4555641/24
Name : M/S. MARK ENTERPRISES
Address : FACTORY ADDRESS: SHED NO.1, PLOT NO. 93/2, STREET NO.17,
MIDC, SATPUR, NASHIK-422007, MAHARASHTRA, INDIA.
1 Set, Tubing And Support, Ventilator (W Harness) - FULLY AUTOMATIC ADULT & PREDIATRIC (MVTR-01,MVTR-02,MVTR-03)
2 Hospital Chair (MHC-01, MHC-02, MHC-03, MHC-04, MHC-05, MHC-06, MHC-07, MHC-08, MHC-09, MHC-10, MHC-11)
3 Tables- Hospital Table(MHT-01,MHT-02, MHT-03, MHT-04, MHT-05, MHT-06, MHT-07 )/ Operation Table(MOT-01,MOT-02,MOT-03)
Beds-Hospital Bed (MHB-01, MHB-02,MHB-03,MHB-04,MHB-05,MHB-06,MHB-07)/ ICU Bed (MICU-01,MICU-02,MICU-03)/ Pediatric Bed (MPB-
4 01,MPB-02,MPB-03)/ Ward plain Bed (MWPB-01,MWPB-02,MWPB-03)/ Semi fowler Bed (MSB-01,MSB-02,MSB-03)/ Electric Bed (MEB-01,MEB-
02,MEB-03)
5 Hospital Trolley (MHTR-01, MHTR-02, MHTR-03, MHTR-04, MHTR-05, MHTR-06, MHTR-07)
6 Bedside Screen (MBS-01, MBS-02,MBS-03,MBS-04)
7 Lockers (ML-01,ML-02,ML-03)
8 Baby furniture (MEBF-01, MEBF-02, MEBF-03,MEBF-04,MEBF-05)
9 Blood Bag Tube Sealer/Dielectric Tube Sealer(MBBTS-01, MBBTS-02, MBBTS-03, MBBTS-04, MBBTS-05)
10 Blood Tube Striper (MBTS-01,MBTS-02,MBTS-03)
11 Incubator-(MINC-01,MINC-02,MINC-03,MINC-04,MINC-05) / BOD Incubator(MBODI-01, MBODI-02, MBODI-03, MBODI-04, MBODI-5)/ Gel Card
Incubator (MGI-01,MGI-02,MGI-03)/CO2 Incubator(MCOI-01,MCOI-02,MCOI-03,MCOI-04,MCOI-05)
12 Plasma Thawing Bath(MPTB-01, MPTB-02, MPTB-03, MPTB-04)
13 Platelet Incubator with Agitator (MPAI-01,MPAI-02,MPAI-03,MPAI-04, MPAI-05)/ Agitator (MAG-01,MAG-02,MAG-03)
14 Refrigerated Cryoprecipitated/Water Bath (MCB-01,MCB-02,MCB-03,MCB-04,MCB-05)
15 Plasma Expressor (MPE-01,MPE-02,MPE-03,MPE-04)
16 Hot Air Oven(MHAO-01, MHAO-02,MHAO-03,MHAO-04,MHAO-05)
17 Serological Water Bath (MSWB-01, MSWB-02, MSWB-03, MSWB-04, MSWB-05)
18 Refrigerated Centrifuge-(MRC-01, MRC-02, MRC-03, MRC-04, MRC-05)/ Non-Refrigerated Centrifuge-(MNRC-01,MNRC-02,MNRC-03,MNRC-
04,MNRC-05)/ Gel Card Centrifuge (MGC-01,MGC-02,MGC-03)/ Lab Centrifuge (MLC-01, MLC-02, MLC-03, MLC-04,)
19 Insulated Vaccine Transporter (MAVT-01,MAVT-02,MAVT-03 , MAVT-04, MAVT-5)
20 Blood Bank Refrigerator/Blood Storage Cabinet (MBBR-01, MBBR-02, MBBR-03,MBBR-04, MBBR-05,MBBR-06, MBBR-07)
21 Deep Freezer -15°C to -25°C (MDFH-01, MDFU-26,MDFU-27,MDFU-28,MDFU-29,MDFU-30)
22 Ice Lined Refrigerator (MILR-01, MILR-02, MILR-03, MILR-04, MILR-05, MILR-06, MILR-07)
23 Solar Operated Medical Cold Chain Equipment- Freezer/Cold Box/Walk in Cooler/Walk In Freezer)
24 Walk In Cooler/Coldroom/Modular Cold Room (MWIC-01, MWIC-02 ,MWIC-03, MWIC-04, MWIC-05, MWIC-06)
25 Walk In Freezer (MWIF-01,MWIF-02,MWIF-03,MWIF-04,MWIF-05,MWIF-06)
26 Deep Freezer-10°C to -40°C (MDFU-13, MDFU-14,MDFU-15,MDFU-16,MDFU-17,MDFU-18,MDFU-19.)
27 Blast Freezer (MDFU-1, MDFU-2)
28 Ultra Low Temperature Laboratory Deep Freezer -50°C to -86°C (MDFU-3,MDFU-4,MDFU-5,MDFU-6,MDFU-7, MDFU-8, MDFU-9,MDFU-10,MDFU-
11,MDFU-12, MDFU-20,MDFU-21,MDFU-22,MDFU-23,MDFU-24,MDFU-25.)
29 Refrigerated Truck (MRT-01,MRT-02,MRT-03,MRT-04)/ Refrigerated Van (MVAN-01,MVAN-02,MVAN-03,MVAN-04)
30 Tables- Hospital Table(MHT-01,MHT-02, MHT-03, MHT-04, MHT-05, MHT-06, MHT-07 )/ Operation Table(MOT-01,MOT-02,MOT-03)
Authorised Signatory
UKAF CERT Limited
130 Thessaly Rd, Nine Elms,
London SW85EJ, UK
Email: info@[Link]
Website: [Link]
Accredited by United Kingdom Accreditation Forum Certification Limited (UKAF)
130 Thessaly Rd, Nine Elms, London SW85EJ, United Kingdom
The Approval is subject to the company maintaining its system to the required standards, which will be monitored by
UKAF CERT Limited. The Certificate remains the property of UKAF CERT Limited and must be returned on request.
To check the Validity of this certificate please visit on [Link]
CERTIFICATE O
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This is to certify that of
ANNEXURE-2
ANNEXURE TO CERTIFICATE NO : IQC/CEP4555641/24
Name : M/S. MARK ENTERPRISES
Address : FACTORY ADDRESS: SHED NO.1, PLOT NO. 93/2, STREET NO.17,
MIDC, SATPUR, NASHIK-422007, MAHARASHTRA, INDIA.
31 Ice pack -(MIP-01, MIP-02,MIP-03,MIP-04)
32 RH View Box-(MRHB-01, MRHB-02, MRHB-03)
33 Frost Freezer-( MFF-01,MFF-02,MFF-03, MFF-04,MFF-05)
34 Laboratory Refrigerator (MLR-01,MLR-02,MLR-03,MLR-04,MLR-05, MLR-06)
35 Blood Donation Van (MBV-01,MBV-02,MBV-03)
36 Autoclave Machines (MACL-01,MACL-02,MACL-03,MACL-04)
37 Laminar Air Flow-Biosafety Cabinet Class II (MLAF-01, MLAF-02, MLAF-03, MLAF-04, MLAF-05,MLAF-06)
38 Blood Donor Couch/Blood Donor Chair (MBDC-01,MBDC-02,MBDC-03,MBDC-04,MBDC-05)
39 Blood Collection Monitor (MBCM-01,MBCM-02,MBCM-03,MBCM-04,MBCM-05)
40 Double Pan Balance-( MDPB-01, MDPB-02,MDPB-03,MDPB-04)
41 Data Logger (MTM-01,MTM-02,MTM-03)
42 Programable Remote Temperature and Event Monitoring System (MTEMS-01,MTEMS-02,MTEMS-03)
43 Elisa Reader (MER-01,MER-02, MER-03, MER-04) /Elisa Washer (MEW-01, MEW-02, MEW-03,MEW-04)
44 Sperm/Semen Warmer (MSW-01, MSW-02, MSW-03)
45 VDRL Shaker (MVDRL-01, MVDRL-02, MVDRL-03,MVDRL-04)
46 PH Meter (MPM-01,MPM-02)
47 Sterile Connecting Device (MSCD-01, MSCD-02, MSCD-03)
48 Microscope (MMB-01, MMB-02,MMB-03,MMB-04)
49 Cold Box (MCBX-01,MCBX-02,MCBX-03,MCBX-04,MCBX-05,MCBX-06 )
50 Vaccine Carrier (MVC-01, MVC-02, MVC-03, MVC-04, MVC-05, MVC-06)
51 Active Cold Box (MACB-01, MACB-02, MACB-03, MACB-04, MACB-05, MACB-06)
52 Dental Equipment and Accessories
53 Voltage Stabilizer (MESCVS-01, MESCVS-02, MESCVS-03, MESCVS-04, MESCVS-05)
54 Sterilizers (MESZ-01,MESZ-02,MESZ-03,MESZ-04)
55 Ultrasonic Cleaner/Cleanser (MEUC-01,MEUC-02,MEUC-03)
56 Examination Table (MET-01, MET-02, MET-03,MET-04,MET-05)
57 Medical Hospital Lamps (MHL-01, MHL-02, MHL-03, MHL-04, MHL-05, MHL-06, MHL-07)
58 Cell Counter (MCC-01,MCC-02,MCC-03,MCC-04,MCC-05)
Authorised Signatory
UKAF CERT Limited
130 Thessaly Rd, Nine Elms,
London SW85EJ, UK
Email: info@[Link]
Website: [Link]
Accredited by United Kingdom Accreditation Forum Certification Limited (UKAF)
130 Thessaly Rd, Nine Elms, London SW85EJ, United Kingdom
The Approval is subject to the company maintaining its system to the required standards, which will be monitored by
UKAF CERT Limited. The Certificate remains the property of UKAF CERT Limited and must be returned on request.
To check the Validity of this certificate please visit on [Link]
CERTIFICATE O
M
ACC
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IT E D K IN
RU
M C E RT I
OF COMPLIANCE
UN
FI
UKAF CERT
C
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* ION
LIMITED
This is to certify that of
ANNEXURE-3
ANNEXURE TO CERTIFICATE NO : IQC/CEP4555641/24
Name : M/S. MARK ENTERPRISES
Address : FACTORY ADDRESS: SHED NO.1, PLOT NO. 93/2, STREET NO.17,
MIDC, SATPUR, NASHIK-422007, MAHARASHTRA, INDIA.
59 Digital Hemoglobinometer (MDHM-01,MDHM-02,MDHM-03,MDHM-04)
60 Hemoglobinostrips (MHS-01,MHS-02,MHS-03)
61 Needle Destroyer (MND-01,MND-02,MND-03,MND-04)
62 Bacteriological Incubator (MBI-01,MBI-02,MBI-03,MBI-04,MBI-05,MBI-06)
63 Research Centrifuge System (MRCS-01,MRCS-02,MRCS-03,MRCS-04,MRCS-05)
64 Rotary Flask Shaker (MRFS-01,MRFS-02,MRFS-03,MRFS-04)
65 Refrigerator Cum Freezer (MFR-01,MFR-02, MFR-03, MFR-04, MFR-05,MFR-06,MFR-07)
66 Hematology Analyzers (MHA-01,MHA-02,MHA-03,MHA-04,MHA-05)
67 Automated blood component extractor (MBCE-01,MBCE-02,MBCE-03,MBCE-04,MBCE-05)
68 Automated Blood Collection System (MBCS-01,MBCS-02,MBCS-03,MBCS-04,MBCS-05)
69 Blood Grouping & Crossmatching Analyzer (MBGCA-01,MBGCA-02,MBGCA-03,MBGCA-04)
70 Hemoglobin Analyzer (MEHA-01,MEHA-02,MEHA-03,MEHA-04)
71 Automated Immunoassay System (MIS-01,MIS-02,MIS-03,MIS-04 )
72 Apheresis Machine (MIS-01,MIS-02,MIS-03,MIS-04)
73 Blood Irradiators (MBIR-01,MBIR-02,MBIR-03,MBIR-04)
74 Automated Platelet Collection Systems (MPCS-01,MPCS-02,MPCS-03,MPCS-04)
75 PRT System (MPRT-01,MPRT-02,MPRT-03,MPRT-04)
76 Rolling hypothermia treatment carts (MRTC-01,MRTC-02, MRTC-03,MRTC-04)
77 Mobile Refrigerator Storage Cold Drawers (MMSCD-01,MMSCD-02,MMSCD-03,MMSCD-04,MMSCD-05)
78 Magnetic Stirrers (MEMS-01,MEMS-02,MEMS-03,MEMS-04)
79 Blood Cell Separator (MCS-01,MCS-02,MCS-03,MCS-04)
80 Blood Warmer (MBW-01,MBW-02,MBW-03,MBW-04)
81 Humidity Chambers (MEHC-01,MEHC-02,MEHC-03,MEHC-04,MEHC-05)
82 Digital Analytical Balance (MDAB-01,MDAB-02,MDAB-03,MDAB-04)
83 Donor Weighing Scale (MEWS-01, MEWS-02, MEWS-03, MEWS-04 )
84 Stem Alcohol Thermometer (MSAT-01,MSAT-02,MSAT-03,MSAT-04)
Authorised Signatory
UKAF CERT Limited
130 Thessaly Rd, Nine Elms,
London SW85EJ, UK
Email: info@[Link]
Website: [Link]
Accredited by United Kingdom Accreditation Forum Certification Limited (UKAF)
130 Thessaly Rd, Nine Elms, London SW85EJ, United Kingdom
The Approval is subject to the company maintaining its system to the required standards, which will be monitored by
UKAF CERT Limited. The Certificate remains the property of UKAF CERT Limited and must be returned on request.
To check the Validity of this certificate please visit on [Link]
