Certificate No.: Project No.

: Valid Until
11322-2017-CE-IND-NA-PS Rev. 3.0 PRJC-195663-2009-PRC-IND 22 January 2024

This is to certify that the quality system of:

Romsons International (Unit - II)

59 J(C) & 9, Noida Special Economic Zone, Noida Dadri Road, Phase II, Noida- 201 305,
Uttar Pradesh, India

For design, production and final product inspection/testing of:

Sterile Disposable Medical Devices

Has been assessed with respect to:

The conformity assessment procedure described in Annex II
excluding section 4 of Council Directive 93/42/EEC on Medical
Devices, as amended

and found to comply

Further details of the product(s) and conditions for certification are given overleaf.

Place and date: For the issuing office:

Høvik, 18 May 2021 Notified Body 2460
DNV Product Assurance AS
Check Validity

Hazem Tinawi
Technical Reviewer

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com ICP-4-5-i1-MDD-f2, rev.0
 Certificate No.: 11322-2017-CE-IND-NA-PS Rev.3.0
Place and date: Høvik, 18 May 2021

Jurisdiction

Application of Council Directive 93/42/EEC of 14 June 1993, adopted as “Forskrift om Medisinsk

Utstyr” by the Norwegian Ministry of Health and Care Services.

Certificate history:
Revision Description Issue Date
Supersedes DNVGL (NB 0434) Certificate no: 70824-
0.0 2010-CEIND-NA Rev. 4.0 following transfer to notified 2017-11-14
body functions to DNV GL Nemko Presafe AS (NB
2460)
1.0 Recertification Audit 2019-01-25
2.0 Site Addition 2021-03-15
3.0 Scope Extension 2021-05-18

Products covered by this Certificate:

Product Description Product Name Class

Sterile Disposable Medical Devices

For Infusion Therapy:

I.V. Cannula Intra Cath-2, Intraflon, Vein Cath, Vennula IIa

Size- 14,16, 18, 20, 22, 24 G
Neo Cath 24 G, Micron 26 G Triflon Size-
18G, 20G, 22G
Scalp Vein Set NG 18, 19, 20, 21, 22, 23, 24, 25 IIa

Umbilical Catheter FG 3.5, 4.0, 5.0, 6.0, 8.0 IIa

CVP Manometer IIa

Three Way Stop Cock Bivalve, Bivalve (Lipid Resistant) Bivalve IIa
Marvel

Peritoneal Dialysis Set Peritoneal Dialysis Catheter Set (Adult & IIa
Child) Peritoneal Dialysis Transfusion Set

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com ICP-4-5-i1-MDD-f2, rev.0

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 Certificate No.: 11322-2017-CE-IND-NA-PS Rev.3.0
Place and date: Høvik, 18 May 2021

Kwill / Filling Cannula IIa

Luer Lock Connector Closure Female Luer Lock Connector - Closure Cap IIa
Caps (Long CAP)
Male Luer Lock Connector - Closure Cap
(Round CAP)

Pressure Monitoring Lines PM-O-Lines (50, 100, 150, 200 cm) IIa
PM-O-Lines-Spiral (200 cm)
PM-O-Lines with Stop Cock (50, 100, 150,
200 cm)
Hi-Line (PE 100, 150, 200), Hi-Line 'Spiral
(200 cm)

Extension Lines Vein-O-Line (10, 50, 100, 150, 200 cm)

Vein-O-Line 'L' (10, 50, 100, 150, 200 cm) IIa
Vein-O-Line 'T' (13 cm) Romo Trol

Extension Lines with Swabable Exteena Uno, Exteena Duo, Exteena Trio,
IIa
Needle Free Port Safsite

Infusion Set with Needle RMS Vented Infusion Set (GS-3060N)

Inflow Vented Infusion Set (GS-3326N)
Romotrol (GS-3097N)
Trans Flow (GS-3063N) IIa
Steri Set (GS-3310N)
Microperf (GS-3064)
RMS Non-Vented Infusion Set (GS-3062)
Non-Vented Infusion Set (GS-3314)
Burette Infusion Set with Volumetric Set 150 ml (GS-3094N)
Needle Volufix 100 ml (GS-3082N) IIa
Measured Volume Infusion Set 100/ 150 ml
(GS-3057)
For Gastroe nte rology:

Naso Gastric Tube Ryles Tube (FG 8, 10, 12, 14, 16, 18, 20)
Romolene (FG 8, 10, 12, 14, 16, 18, 20)
Gastrolene (12, 14, 16) IIa
Levin's Tube (FG 8, 10, 12, 14, 16, 18, 20)
Salem Tube (FG 10, 12, 14, 16, 18, 20)
Infant Feeding Tube (FG 4, 5, 6, 7, 8, 9)

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com ICP-4-5-i1-MDD-f2, rev.0

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 Certificate No.: 11322-2017-CE-IND-NA-PS Rev.3.0
Place and date: Høvik, 18 May 2021

Graduated infant feeding Tube Feedy (FG 5,

6, 7, 8, 9, 10)

For Anaesthe sia:

Tracheal Tubes Endotracheal Tube – Plain, Cuffed, Reinforced IIa

Nasopharyngeal Airways 6.5, 7, 7.5, 8, 8.5 mm IIa

Guedel Airways Size 000, 00, 0, 1, 2, 3, 4, 5 IIa

Tracheostomy Tube Plain (Size 3.5, 4, 4.5, 5, 6, 7, 7.5, 8, 9, 10 IIa

mm)
Cuffed (Size 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10
mm)
Suction Catheter Plain, Thumb Control, Fingertip (FG 5, 6, 8, IIa
10, 12, 14,16, 18)
Mucus Extractor and Mucus With Filter/ without Filter FG 10, 12, 14 IIa
Trap

T-Piece Catheter Mount, Trachea Tee, Trachea Tee IIa

Plus
Anaesthesia Breathing Circuits Bains Circuits, Paediatric Anaesthesia Circuit IIa

Ventilator Circuits Plain/with HME Filter/with single water trap/ IIa

with Double water trap/ Disposable HME Filter
Oxygen Delivery Devices Oxy Set (Twin Bore Nasal Oxygen Set) Adult, IIa
Child, Neo
For Urology:

Male Cath Small, Medium Large, Extra Large, Extra- IIa

Extra Large
Nelaton Catheter Male & Female Nelaton Catheter, Urethral IIa
Catheter.
Foley Balloon Catheter Uro Cath 2 way & 3 way (Adult), IIa
Foley Trac 2 way (Paediatric + Adult),
Foley Trac 3 way (Adult),
Silko Cath 2 way (Paediatric + Adult),
Silko Cath 3 way (Adult), Urosis
For Surge ry & Wound Drainage :

Thoracic Drainage Catheter Chest Drainage Catheter - Straight/Right Angle, IIa

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com ICP-4-5-i1-MDD-f2, rev.0

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 Certificate No.: 11322-2017-CE-IND-NA-PS Rev.3.0
Place and date: Høvik, 18 May 2021

Flexo Cath - Straight/Right angle,

Trocar Catheter
Under Water Seal Drainage Romo Seal - Adult, Midi, Kid IIa

Yankaur Suction Set Tip-Size-Fine, Mini, Midi, Maxi. IIa

Handle-Crown/Standard/Micro, Vaccu Suck
Suction Connecting Tube With Moulded Connectors/without IIa
Connectors, Conductive Tube, Suction
Connecting Tube with Integral Funnel Ends,
Suction Drainage Tube, Suction Extension
Line
Closed Wound Suction Unit Romo Vac Set, Mini Vac Set, Flat Drain Set, IIa
Redon Drain Catheter with& without Trocar/
Needle Attached.

The complete list of devices is filed with the Notified Body

Sites covered by this certificate

Site Name Address

Romsons International Unit II 59 J(C), Noida Special Economic Zone, Noida

Dadri Road, Phase II, Noida – 201 305, Uttar
Pradesh, India.

Romsons International Unit II 9, Noida Special Economic Zone, Noida Dadri

Road, Phase-II, Noida-201305 (INDIA)

EU Representative
OBELIS S.A., Bd. Général Wahis 53, 1030 Brussels,
Belgium, Tel: +32.2.732.59.54, Email: mail@obelis.net

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com ICP-4-5-i1-MDD-f2, rev.0

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 Certificate No.: 11322-2017-CE-IND-NA-PS Rev.3.0
Place and date: Høvik, 18 May 2021

Terms and conditions

The certificate is subject to the following terms and conditions:
• Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a
defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning
liability of defective products.
• The certificate is only valid for the products and/or manufacturing premises listed above.
• The Manufacturer shall fulfil the obligations arising out of the quality system as approved
and uphold it so that it remains adequate and efficient.
• The Manufacturer shall inform the Notified Body of any intended updating of the quality
system and the Notified Body will assess the changes and decide if the certificate remains
valid.
• Periodical audits will be held, in order to verify that the Manufacturer maintains and applies
the quality system. the Notified Body reserves the right, on a spot basis or based on
suspicion, to pay unannounced visits.
The following may render this Certificate invalid:
• Changes in the quality system affecting production.
• Periodical audits not held within the allowed time window.

Conformity declaration and marking of product

When meeting with the terms and conditions above, the producer may draw up an EC declaration
of conformity and legally affix the CE mark followed by the Notified Body identification number.

End of Certificate

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com ICP-4-5-i1-MDD-f2, rev.0

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