Certificate of Compliance
We hereby declare that the technical files of all the items in each product group
complies with the requirements of the Council Directive on Medical Devices
93/42/EEC as Amended 2007/47/EC Class I.
Certificate No.: CE-3331
Manufacturer : BIRD MEDITECH
Address : 109, 110, NIDHI INDL. ESTATE, SHIV SHANKAR COMPLEX
NO.2, N.H. 8, WALIV, VASAI EAST, DIST. PALGHAR,
M.S.401208, INDIA
Products : AS PER APPENDIX PAGE 1
Models : AS PER APPENDIX PAGE 1
Complies with the requirements applicable to it
The quality system file has been assessed, approved and is subject to continuous surveillance
according to the Council Directive on Medical Devices 93/42/EEC as Amended 2007/47/EC
class I.
This certificate is issued under the following conditions:
1. It applies only to the quality system maintained in the manufacture 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 systems are
changed.
3. The certificate validity is conditioned by positive results or surveillance audits.
The CE mark as shown above can be used, under the responsibility of the manufacturer, after
completion of an EC Declaration of conformity and compliance with all relevant EC Directives.
The statement is based on a single evaluation of test report of one sample of above mentioned
product. It does not imply an assessment of the whole production.
Validity of this certificate can be verified at www.ukcertifications.org.uk/verify
Date of Certification 18th July 2022
1st Surveillance Audit Due 17th July 2023
2nd Surveillance Audit Due 17th July 2024
Certificate Expiry (subject to the company maintaining its 17th July 2025
system to the required standard)
Authorised Signatory Page 1 of 2
Certificate of Compliance Appendix-I
Appendix to Certificate no.:- CE-3331
Manufacturer : BIRD MEDITECH
This certificate referred to above covers the following products like:
Product Name & Models :
Sr. No. Product Name Class & Rule Models
1 Infant Radiant Warmer Class IIb & Rule-9 Innova, Innova-Lite, Inspiration,
Hybrid (Model : BM-3100) &
Neonatal Intensive Care Unit
(Model : Inspiration Plus)
(Options for Innova : Fixed
Bassinet, Fixed Bassinet with
Drawers, Stand, Stand with
detachable bassinet, Options for
Inspiration : Neonatal
Resuscitation unit with
accessories, with T-piece
Resuscitator)
2 Phototherapy System Class IIb & Rule-9 LED (L9 & L15) & CFL
(Options : Over Surface Stand,
Under Surface, Over Surface
stand with Bassinet, Double
Surface)
3 Bubble CPAP Class IIb & Rule-11 Alveo, Res-P-Line, Res-P, Neo-
Res, Inno-Res & Res-Q-Puff
4 High Flow Nasal Oxygen Class IIb & Rule-11 BM-HFNC
Therapy Unit
5 Respiratory Humidifier Class IIb & Rule-11 HHD-01 & HD-PLUS
6 Manual Resuscitation Bag Class IIb & Rule-9 Adult, Child & Neonate
7 Oxygen Hood Class-I Small & Medium
(Polycarbonate)
8 Neonatal Incubator Class IIb & Rule-9 INC-3000 & Transport Incubator
INC-3000T
9 Infusion Pump BM-VP-500
10 Syringe Pump BM-SP-500 & MS-51
11 Vein Finder PL800
12 Patient Monitor Class IIA & Rule-9 BM-K10, BM-K12, BM-K15
& 5 Parameters
13 Video Laryngoscope Class IIA & Rule-9 BM-VLS3R (with Reusable
Blades)
BM-VLS3D (with Disposable
Blades)
Authorised Signatory Page 2 of 2
This is to Certify that the Management System of
Bird Meditech
109, 110, Nidhi Industrial Estate, Shiv Shankar Industrial Complex
No. 2, N.H. No. 8, Village Waliv, Vasai (East) 401208, District
Palghar, Maharashtra, India
.has been audited and found to comply with the requirements of:
ISO 13485:2016
(Medical Devices – Quality Management System)
For the Scope of activities described below:
Design, Manufacture and Supply of Electro - Medical Devices like Radiant Heat Warmers,
Neonatal Resuscitation Units, Continuous +ve Airway Pressure Systems,
Phototherapy Systems, Manual Resuscitation Units, Weighing Scales,
Oxygen Hood, Infusion Pumps, Incubator, Patient Monitors,
Video Laryngoscope and Disinfectants
Certificate No.: IN92690H
Date of initial registration Date of this Certificate Surv. audit on or before/ Certificate expiry Recertification Due
27 April 2021 22 April 2023 26 April 2024 26 April 2024
Validity of this certificate is subject to successful completion of surveillance audit on or before due date,
in case surveillance audit not conducted this certificate shall be suspended/cancelled.
Director
BIRD MEDITECH
109, 110, NIDHI INDL. ESTATE, SHIV SHANKAR COMPLEX NO.2, N.H. 8, WALIV,
VASAI EAST, DIST. PALGHAR, MAHARASHTRA- 401208, INDIA
has been independently assessed by QRO
and is compliant with the requirement of:
ISO 9001:2015
Quality Management System
For the following scope of activities:
MANUFACTURING, RESEARCH AND DEVELOPMENT AND
RESELLING OF ELECTRO-MEDICAL EQUIPMENT FOR HOSPITALS
Date of Certification: 18th October 2022 2nd Surveillance Audit Due: 17th October 2024
1st Surveillance Audit Due: 17th October 2023 Certificate Expiry: 17th October 2025
Certificate Number: 305022101873Q
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} BUREAU OF INDIAN STANDARDS
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Licence for the use of STANDARD MARK
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LICENCE NO. CM/L-7700202730
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By virtue of the power conferred on it by the BUREAU OF INDIAN STANDARDS ACT, 2016
( 11 of 2016) the BUREAU hereby grants to
M/s BIRD MEDITECH
1 09. 1 10, NIDHI INDUSTRIAL ESTATE,SHIV SHANKAR
COMPLEX NO. 2.NH NO. 8. WALIV. VASAI (E)
PALGHAR – 401208
MAHARASHTRA.INDIA
(hereinafter called the Licensee) this Licence to use the Standard Mark set out in the first column of
the Schedule hereto, upon or in respect of the varieties set out in the third column of the said
Schedule which is manufactured in accordance with/conforms to the related Indian Standard(s)
referred to in the second column of the said Schedule as from time to time amended or revised.
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2. This
Licence carries obligations on pan of the licensee as conditions of licencewhich are given in
Annexure attached herewith. This licence shall be valid for the name, factory address and period as
mentioned in the schedule and may be renewed as specified in the Scheme-l.
Page 1 of 4
'rIM
SCHEDULE
aTJRfRt. gIFT/Tv–7700202730
Licence No.CM/L-7700202730
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NAME M/s. BIRD MEDITECH
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FACTORY ADDRESS: 109. 1 10, NIDH! INDUSTRIAL ESTATE.SHIV SHANKAR.COMPLEX NO. 2,NH NO. 8,
WALIV. VASAI (E),PALGHAR – 401208, MAHARASHTRA,INDIA
tVTT f+Ttq -,05-12-2023 + 04-12-2024
VALIDITY FROM : 05-12-2023 TO 04-12-2024
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Standard Mark
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Indian Standard
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Marking Fee
(1) (2) (3) (4)
IS 13450 : VT qT 13450 : PART
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PART 2 : 2 : SEC 21 :2023
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SEC 21 50H,, tt? #:: 5A, 3qFPr Tr Tm: 45 f%lit7TT, THt ?166000/- pq Hrm qf
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Name of the Product: Medical Electrical Equipment - Infant
Radiant Warmer. Model- Innova. Rated Voltage: 230V. AC. Rs.30/- Per unit for all
Units
IS 13450 : PART 2 : Single Phase, Rated Frequency: 50Hz, Rated Current: SA,
SEC 2 1 :2023
With a minimum marking
Weight of Equipment: 45 kgs, Protection against Harmful
fee of Rs. 166000/- During
Switches for ingress of water: I PXO,Functions: without Oxvgen an operative period of One
domestic and similar monitor/controller. without integrated weighing scale, without Year.
purposes C02 concentrator, with pre-warm mode. without internal IUnit = 1 Piece
battery, Mode of Operation: Continuous Operation, Protection Minimum Marking Fee for
against Electric Shock: Class I.Suitability for use in oxygen One operative year payable
in advance which will be
rich environment: Not suitable, Types and number of probes: carried over to next
Type BF applied pans with two probes. renewal (s).
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BUREAU OF INDIAN STANDARDS
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(SATISH KUMAR )
Sc. F,Senior Director & Head (IVIUBO-1)
Page 2 of 4
Annexure
(LicenceNo.CM/L – 7700202730)
Conditions of the licence
(1) The design of Standard Mark shall be identical to the facsimile given in the licence.
(2) The photographic enlargement or reduction of the Standard Mark may also be used,
unless otherwise specified by the Bureau.
(3) The licensee shall be responsible for the conformity of the goods, article, process,
system or service to the Indian Standard in relation to which Standard Mark is used or
applied.
(4) The licensee shall not use the Standard Mark in relation to goods, articles, process,
system or service which are non –conforming or outside the scope of the licence.
(5) if goods and articles in relation to which a Standard Mark has been used do not conform
to the requirements of the relevant standard, the Bureau may direct the licensee or his
representative to recall such non-conforming goods.
(6) The Standard Mark shall not be used or applied in relation to any goods, article, process,
system or service during deferment or suspension, or, after expiry or cancellation of the
licence
(7) The licensee shall comply with the provisions of the conformity assessment scheme
under which licence is granted, including labelling and markingrequirements.
(8) The licensee shall maintain records as specified by the Bureau from time to time.
(9) The licensee shall provide the Bureau all assistance in connection with carrying out
inspection or audit at its premises and Such Assistance Shall Include Sending Samples
Which Have Been Marked And Sealed By The Certification Officer To The Designated Office
Or Laboratory And Ensuring That Such Sample is Dispatched To The Designated Office Or
Laboratory Within Seven Days From The Date Of Inspection, Audit Or Evaluation.
(10) The licensee shall provide information relating to production and use or applying of
Standard Mark as and when it is required by the Bureau.
(11) if the licence is granted to use or apply Standard Mark on goods or articles, the licensee
shall provide the list of consignees, distributors, dealers or retailers to whom goods or
articles with Standard Mark is supplied.
(12) The licence shall not be transferred to any person without approval of the Bureau.
(13) if a complaint regarding quality of any goods, article, process, system or service
bearing Standard Mark is established, the Bureau may direct the licensee or his
representative to repair or replace or reprocess the standard marked goods and articles.
(14) The Bureau shall have the right to amend any of the conditions of licence by giving a
. notice of not less than one month to the licensee.
Page 4 of 4
Pdt&T_V4%ipL&; #.ePH
D ate: 14thFeb, 2024
To,
DY CMO KHERI
CMO Office, Barabanki
Medical Health and Family Welfare
Department Uttar Pradesh
OUR AUTHORIZED SERVICE CENTRES
OUR LOCAL SERVICE CENTRE DETAILS:-
1st Escalation: 2nd Escalation:
Medical Systems & Services Medical Systems & Services
C/O Bird Meditech C/O Bird Meditech
In front of Bhawna Hospital, 101, Express Market, LSC, H-Block,
Padleygunj Road, Deoria By Pass, Ashok Vihar, Phase-I, Delhi-110052
Gorakhpur - 273001 (UP) Toll Free No.: 18001034739
Toll Free No.: 18001034739 Email ID:
[email protected]Email ID:
[email protected]Contact Person: Mr. Chandrashekar Contact Person: Mr. Praween Jha
Contact Number: 9350044128 Contact Number: 9350536299
