FORM MD-6

[See sub-rule (4) of rule 20 and sub-rule (6) of rule 20]

Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device

Loan Licence Number: MFG/MD/2023/000480

1. M/s SWASTIK MEDICA PRIVATE LIMITED, SHOP NO.93,SECTOR-

40,GURGRAM,GURGAON,HARYANAGURGAON, Gurgaon, Haryana (India) - 122001 Telephone No.: 09717169333
FAX: 0124-4614383 has been licenced to manufacture for sale or for distribution the below listed medical device(s) at
the premises situated at M/s PHOENIX INNOVATIVE HEALTHCARE MANUFACTURERS PRIVATE LIMITED, EL-
209, Shil Mahape Road, Electronic Zone, MIDC TTC Industrial Area, Mahape, Navi Mumbai, Thane, Maharashtra
(India) - 400710 Telephone No.: 022-27615808 FAX: 022-27615808
2. Details of medical device(s) [Annexed]

3. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.

ANNEXURE
[Link]. Details Of Device(s)
Generic Name:Alcohol Prep Pads
1
Model No.:NIL
Intended Use:Alcohol Prep Pad is used for preparation of skin prior to injection
Class of medical device:Class A
Material of construction:Non woven Cloth, Isopropyl Alcohol, Aluminium foil
Dimension(if any):-
Shelflife:60 Months
Sterile or Non sterile:Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-
Generic Name:Blood Pressure Monitor
2
Model No.:NIL
Intended Use:The Blood Pressure Monitor is a device used to measure the diastolic and
systolic blood pressures
Class of medical device:Class B
Material of construction:Acrylonitrile Butadiene Styrene (Abstron )
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-

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 Generic Name:Blood Pressure Monitor with USB
3
Model No.:NIL
Intended Use:The Blood Pressure Monitor is a device used to measure the diastolic and
systolic blood pressures
Class of medical device:Class B
Material of construction:Acrylonitrile Butadiene Styrene (Abstron )
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-
Generic Name:Thoracic Suction Pump
4
Model No.:NIL
Intended Use:Powered suction pump is a device intended to generate negative pressure
specifically for aspiration to remove fluids and secretions from the respiratory system to allow
for the normal function of the lungs
Class of medical device:Class B
Material of construction:Acrylonitrile Butadiene Styrene (Abstron )
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-
Generic Name:Steam Vaporizer
5
Model No.:NIL
Intended Use:Steam vaporizer is an electrically powered, handheld device designed for the
inhalation of steam for the relief of the symptoms ( congestion and pressure ) associated with
respiratory disorders
Class of medical device:Class A
Material of construction:Acrylonitrile Butadiene Styrene (Abstron )
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-
Generic Name:Nano Steamer
6
Model No.:NIL
Intended Use:Nano Steamer is an electrically powered handheld device designed for the
inhalation of steam for the relief of the symptoms ( congestion and pressure ) associated with
respiratory disorders. The steam is used for deep cleaning of facial pores thereby providing
facial glow
Class of medical device:Class A
Material of construction:Acrylonitrile Butadiene Styrene (Abstron )
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-

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 Generic Name:Digital Thermometer
7
Model No.:NIL
Intended Use:Digital Thermometer is intended to measure human body temperature orally,
rectally or under the arm
Class of medical device:Class B
Material of construction:Acrylonitrile Butadiene Styrene (Abstron )
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-
Generic Name:Floatation Therapy Bed, Adult / Air Mattress
8
Model No.:NIL
Intended Use:Air Mattress is intended to minimize pressure points on a patient's body by
providing contact with as much of the body surface as possible through a mattress that
contains a large volume of constantly moving air that lifts the patient to Stimulate a floating
effect.
Class of medical device:Class B
Material of construction:Acrylonitrile Butadiene Styrene Body and, Polyvinylchloride
Dimension(if any):-
Shelflife:NIL
Sterile or Non sterile:Non-Sterilized
Brand Name(if registered under the Trade Marks Act, 1999):-
Generic Name:Alcohol Swab
9
Model No.:NIL
Intended Use:It is a single use, sterile device containing 70% Isopropyl alcohol used for
scrubbing and allowing drying and will disinfect needless access sites prior to use..
Class of medical device:Class A
Material of construction:Non woven Cloth, Isopropyl Alcohol, Aluminium foil
Dimension(if any):-
Shelflife:60 Months
Sterile or Non sterile:Both
Brand Name(if registered under the Trade Marks Act, 1999):-

DUSHYANT Digitally signed by DUSHYANT

MOTIRAM BHAMRAY
MOTIRAM Date: 2023.05.15 [Link]

Place: BHAMRAY +05'30'

Date:15-May-23 State Licensing Authority

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