9. LABEL SYMBOLS
Label symbols are shown in the following table:
No.
Symbol
Description
1
BATCH CODE. This symbol should be accompanied by batch
code.
2
Symbol for "SERIAL NUMBER". This symbol shall be
accompanied by the manufacturer's serial number.
3
DATE OF MANUFACTURE. This symbol shall be accompanied
by the date of manufacture.
4
CONSULT INSTRUCTIONS FOR USE.
5
Symbol for "MANUFACTURER". This symbol shall be
accompanied by the name and the address of the manufacturer.
6
“WEEE (Waste Electrical and Electronic Equipment
)”
. The waste
products should be disposed of legally.
7
KEEP DRY.
8
Type BF Applied Part.
9
FRAGILE.
10
THIS SIDE UP.
11
12
DO
NOT STACKING.
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0413
After the adoption of the CE certification, CE mark is as following drawings.
Its vertical height shall not be less than 5mm, clearly visible, clear,
durable.
the CE conformity assessment procedures are made by a Notified
Body the Notified Body registration number should be the side of CE
mark(Usually in the bottom right). The diameter of the CE marking
should be not less than the 5MM semicircle of the two makes up, the
XXXX at the lower right corner is the Notified Body identification
number, such as the ITS-0413. Allmedical products sold in the EU
market must identify the "CE". Affix the CE mark indicates that:
A. The equipment to meet the basic requirements of the MDD;
B. The equipment within the EU can be legally sold in the market;
C. The device has passed a the conformity assessment procedures.
The CE marks affixed to the medical devices have two types. That is,
CE mark without Notified Body identification number and CE Mark
with Notified Body identification number.
