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TruCUT-CO2-Laser-Machine
TruCUT CO2 Laser Machine SAHPRA License for Non-Medical Devices.pdf
Page 5 of 6
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY
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Pretoria
Web:
https://www.sahpra.org.za/radiation-control/
ADVANCED MACHINERY (PTY)LTD
P.O. Box 2312
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Attention:
Mr Eric Yin
- inspections may be performed to ensure that the licence
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Y
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Chief Executive Officer (CEO)
- This updated document contains the licences for devices
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that are currently valid, and replaces the document da
ted 2 March 2015 and all previous
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All Other Devices:
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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY
RADIATION CONTROL
LICENCE HOLDER:
ADVANCED MACHINERY (PTY)LTD
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Signed at Pretoria
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LASERMASTER
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CONDITIONS
LIST OF LICENCES FOR NON MEDICAL DEVICES
HAZARDOUS SUBSTANCES ACT (ACT 15 OF 1973)
Chief Executive Officer (CEO)
0
5
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LICENCE CONDITION 04
a
)
The licence holder must keep a record of every transaction of t
his model, and such record must include the
following information:
(i) Name and address of the purchaser.
(ii) Brand, model and serial number.
(iii) Date of transaction.
b) X-ray unit used for industrial, research, educational, secur
ity or any other purposes, electron or
heavy particle accelerator and a neutron generator
(i) The licence holder must submit form RC-DEALER to the SA
H
P
R
A
.
(ii) Delivery or installation of any unit/component on a pr
e
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has received approval (
R
C
-
D
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A
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stamped "
MAY INSTALL
") from SAHPRA.
c) Class 3b or Class 4 laser device
(i) Details of a transaction (form RC011-1(rev 1)) must be
s
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Control within 21 days after the transaction has been fi
n
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.
(ii) If this model is a Class 3b or Class 4 laser device, th
e
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a
copy of the application form SBLN-1.
(iii) Any unit of this model may only be supplied to the pur
chaser if the purchaser possess documentary proof
that the required licence to use that unit, has been i
ssued by SAHPRA.
d) MRI
(i) Details of a transaction (form RC011-1(MRI)) must be su
b
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within 21 days after the transaction has been final
ised.
(ii) If this model is an MRI device, the licence holder mus
t provide the purchaser with a copy of the application
f
o
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m
S
B
V
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1
.
(iii) Installation of any unit may commence only after the l
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(
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from SAPRA with the following wording stamped on it -
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)
S
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(i) If this model is a sunbed, the licence holder must ensur
e that the sunbed complies with the requirements as
outlined in the document "Requirements for sunbeds inten
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tanning salons, beauty parlours and similar premises".
(ii) The licence holder must provide the purchaser with a co
py of the document "Guidelines for the safe use of
sunbeds". https://www.sahpra.org.za/radiation-control/
Signed at Pretoria
Chief Executive Officer (CEO)
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Name:
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(AM.CO.ZA)
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Manufacturer:
Advanced Machinery (Pty) Ltd
Supplier in
South Africa:
Advanced Machinery (Pty) Ltd
Product Sales
Licence
No:
1360/23331
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Des
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S
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:
Date
:
"
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