Disposable Pneumatic Tourniquet Cuff

ZXD-I-001 ZXD-I-001D
8” Disposable Infant Cuff 8” Disposable Infant
8”L x 2”W 8”L x 2”W
Single Hose ,Single Bladder Dual Hoses, Single Bladder
Light blue Light blue
ZXD-I-002 ZXD-I-002D
12” Disposable Child 12” Disposable Child
12”L x 3”W 12”L x 3”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Modena Modena
ZXD-I-003 ZXD-I-003D
15” Disposable Child Long 15” Disposable Child Long
15”L x 4”W 15”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Grey Grey
ZXD-I-004 ZXD-I-004D
18” Disposable Standard Arm 18” Disposable Standard Arm
18”L x 4”W 18”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Red Red
ZXD-I-005 ZXD-I-005D
24” Disposable Standard Leg 24” Disposable Standard Leg
24”L x 4”W 24”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Yellow Yellow
ZXD-I-006 ZXD-I-006D
30” Disposable Medium Leg 30” Disposable Medium Leg
30”L x 4”W 30”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
White White
ZXD-I-007 ZXD-I-007D
34” Disposable Long Leg 34” Disposable Long Leg
34”L x 4”W 34”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Blue Blue
ZXD-I-008 ZXD-I-008D
42” Disposable Extra Long Leg 42” Disposable Extra Long Leg
42”L x 4”W 42”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Green Green
 Disposable Conical Tourniquet Cuff

ZXD-I-004C ZXD-I-004DC
18” Disposable Standard Arm Conical 18” Disposable Standard Arm Conical
18”L x 4”W 18”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Red Red
ZXD-I-005C ZXD-I-005DC
24” Disposable Standard Leg Conical 24” Disposable Standard Leg Conical
24”L x 4”W 24”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Yellow Yellow
ZXD-I-006C ZXD-I-006DC
30” Disposable Medium Leg Conical 30” Disposable Medium Leg Conical
30”L x 4”W 30”L x 4”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
White White
ZXD-I-007C ZXD-I-007DC
34” Disposable Long Leg Conical 34” Disposable Long Leg Conical
34”L x 5”W 34”L x 5”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Blue Blue
ZXD-I-008C ZXD-I-008DC
42” Disposable Extra Long Leg Conical 42” Disposable Extra Long Leg Conical
42”L x 5”W 42”L x 5”W
Single Hose, Single Bladder Dual Hoses, Single Bladder
Green Green
 Reusable Pneumatic Tourniquet Cuff

ZXD-Ⅱ-001 ZXD-Ⅱ-001D
8” Reusable Infant Cuff 8” Reusable Infant
8”L x 2”W 8”L x 2”W
Single Portal ,Single Bladder Dual Portal, Single Bladder
Light blue Light blue
ZXD-Ⅱ-002 ZXD-Ⅱ-002D
12” Reusable Child 12” Reusable Child
12”L x 3”W 12”L x 3”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Modena Modena
ZXD-Ⅱ-003 ZXD-Ⅱ-003D
15” Reusable Child Long 15” Reusable Child Long
15”L x 4”W 15”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Grey Grey
ZXD-Ⅱ-004 ZXD-Ⅱ-004D
18” Reusable Standard Arm 18” Reusable Standard Arm
18”L x 4”W 18”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Red Red
ZXD-Ⅱ-005 ZXD-Ⅱ-005D
24” Reusable Standard Leg 24” Reusable Standard Leg
24”L x 4”W 24”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Yellow Yellow
ZXD-Ⅱ-006 ZXD-Ⅱ-006D
30” Reusable Medium Leg 30” Reusable Medium Leg
30”L x 4”W 30”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
White White
ZXD-Ⅱ-007 ZXD-Ⅱ-007D
34” Reusable Long Leg 34” Reusable Long Leg
34”L x 4”W 34”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Blue Blue
ZXD-I-008 ZXD-Ⅱ-008D
42” Reusable Extra Long Leg 42” Reusable Extra Long Leg
42”L x 4”W 42”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Green Green
 Reusable Conical Tourniquet Cuff

ZXD-Ⅱ-004C ZXD-Ⅱ-004DC
18” Reusable Standard Arm Conical 18” Reusable Standard Arm Conical
18”L x 4”W 18”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Red Red
ZXD-Ⅱ-005C ZXD-Ⅱ-005DC
24” Reusable Standard Leg Conical 24” Reusable Standard Leg Conical
24”L x 4”W 24”L x 4”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Yellow Yellow
ZXD-Ⅱ-006C ZXD-Ⅱ-006DC
30” Reusable Medium Leg Conical 30” Reusable Medium Leg Conical
30”L x 4”W 30”L x 4”W
Single Hose, Single Bladder Dual Portal, Single Bladder
White White
ZXD-Ⅱ-007C ZXD-Ⅱ-007DC
34” Reusable Long Leg Conical 34” Reusable Long Leg Conical
34”L x 5”W 34”L x 5”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Blue Blue
ZXD-Ⅱ-008C ZXD-Ⅱ-008DC
42” Reusable Extra Long Leg Conical 42” Reusable Extra Long Leg Conical
42”L x 5”W 42”L x 5”W
Single Portal, Single Bladder Dual Portal, Single Bladder
Green Green
 Product Service

CERTIFICATE
No. Q2N 14 10 89449 001

Holder of Certificate: TianTai Typhung Medical

Supplies Co., Ltd
Xiawangqiu Village Fuxi district
317200 Tiantai County, Zhejiang
PEOPLE'S REPUBLIC OF CHINA

Facility(ies): TianTai Typhung Medical Supplies Co., Ltd

Xiawangqiu Village Fuxi district, 317200 Tiantai County, Zhejiang,
PEOPLE'S REPUBLIC OF CHINA

Certification Mark:

Scope of Certificate: Production and Distribution of

Pneumatic Tourniquet Cuff

Applied EN ISO 13485:2012 + AC :2012

Standard(s): Medical devices -Qual ity management systems -
Requirements for regulatory purposes
(ISO 13485:2003 + Cor. 1:2009)
DIN EN ISO 13485:2012

The Certification Body of TOV SOD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system (excluding subclause
7.3), wh ich meets the requirements of the listed standard(s). See also notes overleaf.

Report No.: SH1490701

Valid from: 2015-01-12

Valid until: 2018-01-11

Date, 2015-01 -13

Hans-Heiner Junker

0 Page 1 of 1
(( DAkkS
0PtJtc;c:hP
 Product Service

EC Certificate
Production Quality Assurance System
Directive 93/42/EEC on Medical Devices (MOD), Annex V
(Devices in class I in sterile conditions, sterilised systems or procedure packs)
No. G2S 14 10 89449 002

Manufacturer: TianTai Typhung Medical

Supplies Co., Ltd
Xiawangqiu Village Fuxi district
317200 Tiantai County, Zhejiang
PEOPLE'S REPUBLIC OF CHINA

EC-Representative: KINGSMEAD SERVICE LIMITED

145-157 StJohn Street
London
EC1V 4PY
UNITED KINGDOM

Product Pneumatic Tourniquet Cuff

Category(ies):

The Certification Body of TOV SOD Product Service GmbH declares that the aforementioned
manufacturer has implemented a quality assurance system for manufacture in accordance with
MOD Annex V. This quality assurance system covers those aspects of manufacture concerned
with securing and maintaining sterile conditions of the respective devices I device categories and
conforms to the requirements of this Directive. It is subject to periodical surveillance. See also
notes overleaf.

Report No.: SH1490701

Valid from: 2015-01-12

Valid until: 2020-01-11

Date, 2015-01 -13

Hans-Heiner Junker

TOV SOD Product Service GmbH is Notified Body with identification no. 0123

Page 1 of 2
 ~j
~
Product Service
EC Certificate
Production Quality Assurance System
Directive 93/42/EEC on Medical Devices (MOD), Annex V
(Devices in class I in sterile conditions, sterilised systems or procedure packs)
No. G2S 14 10 89449 002

Facility(ies): TianTai Typhung Medical Supplies Co., Ltd

Xiawangqiu Village Fuxi district, 317200 Tiantai County,
Zhejiang, PEOPLE'S REPUBLIC OF CHINA

Page 2 of 2

TOV SUD Product Service GmbH 0

Zertifizierste lle 0
Rid lerstraBe 65 ° 80339 MOnchen ° Germany
11JV®