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醫(yī)療器械出口銷售證明信息2024年第九期
發(fā)布時(shí)間:2024/11/18 信息來源:查看

??? 根據(jù)《國家食品藥品監(jiān)督管理總局關(guān)于發(fā)布醫(yī)療器械產(chǎn)品出口銷售證明管理規(guī)定的通告》(2015年第18號),現(xiàn)將我局對本行政區(qū)域內(nèi)企業(yè)出具的《醫(yī)療器械產(chǎn)品出口銷售證明》相關(guān)信息進(jìn)行公開。

貴州省藥品監(jiān)督管理局

2024年11月18日

序號

企業(yè)名稱

企業(yè)住所

產(chǎn)品名稱

規(guī)格型號

產(chǎn)品注冊或備案憑證號

生產(chǎn)許可或備案憑證號

證明編號

證明有限日期

1

貴州梓銳科技有限公司

貴州省遵義市桐梓縣楚米鎮(zhèn)貴州婁山關(guān)高新技術(shù)產(chǎn)業(yè)開發(fā)區(qū)1期B棟2樓、3樓

一次性無菌刨刀、一次性無菌一體式刨刀



附件一



黔械注準(zhǔn)20232040030、黔械注準(zhǔn)20232040033

黔食藥監(jiān)械生產(chǎn)許20170016號

黔遵食藥監(jiān)械出202400010號

2024年11月15日至2026年11月14日

??? 附件一

產(chǎn)品名稱:一次性無菌刨刀
Product Name: Disposable Sterile Blade

注冊證書編號:黔械注準(zhǔn)20232040030
Registration Certificate No.: No. 20232040030 by Guizhou Medical Products Administration

序號
No.

型號
Model

規(guī)格
Specification

刀頭型式
Type of Blade

推薦參數(shù)
Recommended parameters

刀桿直徑
Shank DiameterφD(mm)

工作長度
Usable LengthL(mm)

1

PXFSD45385RCD-YCW

4.5

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

1000r/min~
6000r/min

2

PXFSD45385CD-YCW

4.5

385

頂切雙面齒
Double Serrated-Top Cutting

3

PXFSD45385RCL-YCW

4.5

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

4

PXFSD45385CL-YCW

4.5

385

中切雙面齒
Double Serrated-Lateral Cutting

5

PXFSD40385RCD-YCW

4

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

6

PXFSD40385CD-YCW

4

385

頂切雙面齒
Double Serrated-Top Cutting

7

PXFSD40385RCL-YCW

4

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

8

PXFSD40385CL-YCW

4

385

中切雙面齒
Double Serrated-Lateral Cutting

9

PXFSD35385RCD-YCW

3.5

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

10

PXFSD35385CD-YCW

3.5

385

頂切雙面齒
Double Serrated-Top Cutting

11

PXFSD35385RCL-YCW

3.5

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

12

PXFSD35385CL-YCW

3.5

385

中切雙面齒
Double Serrated-Lateral Cutting

13

PXFSD30385RCD-YCW

3

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

14

PXFSD30385CD-YCW

3

385

頂切雙面齒
Double Serrated-Top Cutting

15

PXFSD30385RCL-YCW

3

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

16

PXFSD30385CL-YCW

3

385

中切雙面齒
Double Serrated-Lateral Cutting

17

PXFSD25385RCD-YCW

2.5

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

18

PXFSD25385CD-YCW

2.5

385

頂切雙面齒
Double Serrated-Top Cutting

19

PXFSD25385RCL-YCW

2.5

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

20

PXFSD25385CL-YCW

2.5

385

中切雙面齒
Double Serrated-Lateral Cutting

21

PXFSD45330RCD-YCW

4.5

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

22

PXFSD45330CD-YCW

4.5

330

頂切雙面齒
Double Serrated-Top Cutting

23

PXFSD45330RCL-YCW

4.5

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

24

PXFSD45330CL-YCW

4.5

330

中切雙面齒
Double Serrated-Lateral Cutting

25

PXFSD40330RCD-YCW

4

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

26

PXFSD40330CD-YCW

4

330

頂切雙面齒
Double Serrated-Top Cutting

27

PXFSD40330RCL-YCW

4

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

28

PXFSD40330CL-YCW

4

330

中切雙面齒
Double Serrated-Lateral Cutting

29

PXFSD35330RCD-YCW

3.5

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

30

PXFSD35330CD-YCW

3.5

330

頂切雙面齒
Double Serrated-Top Cutting

31

PXFSD35330RCL-YCW

3.5

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

32

PXFSD35330CL-YCW

3.5

330

中切雙面齒
Double Serrated-Lateral Cutting

33

PXFSD30330RCD-YCW

3

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

34

PXFSD30330CD-YCW

3

330

頂切雙面齒
Double Serrated-Top Cutting

35

PXFSD30330RCL-YCW

3

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

36

PXFSD30330CL-YCW

3

330

中切雙面齒
Double Serrated-Lateral Cutting

37

PXFSD25330RCD-YCW

2.5

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

38

PXFSD25330CD-YCW

2.5

330

頂切雙面齒
Double Serrated-Top Cutting

39

PXFSD25330RCL-YCW

2.5

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

40

PXFSD25330CL-YCW

2.5

330

中切雙面齒
Double Serrated-Lateral Cutting


產(chǎn)品名稱:一次性無菌一體式刨刀
Product Name: Disposable Sterile Integrated Blade

注冊證書編號:黔械注準(zhǔn)20232040033
Registration Certificate No.: No. 20232040033 by Guizhou Medical Products Administration

序號
No.

型號
Model

規(guī)格
Specification

刀頭型式
Type of Blade

推薦參數(shù)
Recommended parameters

刀桿直徑
Shank Diameter
φD(mm)

工作長度
Usable Length
L(mm)


1

PXFYD45385RCD-YCW

4.5

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

1000r/min~
6000r/min

2

PXFYD45385CD-YCW

4.5

385

頂切雙面齒
Double Serrated-Top Cutting

3

PXFYD45385RCL-YCW

4.5

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

4

PXFYD45385CL-YCW

4.5

385

中切雙面齒
Double Serrated-Lateral Cutting

5

PXFYD40385RCD-YCW

4

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

6

PXFYD40385CD-YCW

4

385

頂切雙面齒
Double Serrated-Top Cutting

7

PXFYD40385RCL-YCW

4

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

8

PXFYD40385CL-YCW

4

385

中切雙面齒
Double Serrated-Lateral Cutting

9

PXFYD35385RCD-YCW

3.5

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

10

PXFYD35385CD-YCW

3.5

385

頂切雙面齒
Double Serrated-Top Cutting

11

PXFYD35385RCL-YCW

3.5

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

12

PXFYD35385CL-YCW

3.5

385

中切雙面齒
Double Serrated-Lateral Cutting

13

PXFYD30385RCD-YCW

3

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

14

PXFYD30385CD-YCW

3

385

頂切雙面齒
Double Serrated-Top Cutting

15

PXFYD30385RCL-YCW

3

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

16

PXFYD30385CL-YCW

3

385

中切雙面齒
Double Serrated-Lateral Cutting

17

PXFYD25385RCD-YCW

2.5

385

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

18

PXFYD25385CD-YCW

2.5

385

頂切雙面齒
Double Serrated-Top Cutting

19

PXFYD25385RCL-YCW

2.5

385

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

20

PXFYD25385CL-YCW

2.5

385

中切雙面齒
Double Serrated-Lateral Cutting

21

PXFYD45330RCD-YCW

4.5

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

22

PXFYD45330CD-YCW

4.5

330

頂切雙面齒
Double Serrated-Top Cutting

23

PXFYD45330RCL-YCW

4.5

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

24

PXFYD45330CL-YCW

4.5

330

中切雙面齒
Double Serrated-Lateral Cutting

25

PXFYD40330RCD-YCW

4

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

26

PXFYD40330CD-YCW

4

330

頂切雙面齒
Double Serrated-Top Cutting

27

PXFYD40330RCL-YCW

4

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

28

PXFYD40330CL-YCW

4

330

中切雙面齒
Double Serrated-Lateral Cutting

29

PXFYD35330RCD-YCW

3.5

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

30

PXFYD35330CD-YCW

3.5

330

頂切雙面齒
Double Serrated-Top Cutting

31

PXFYD35330RCL-YCW

3.5

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

32

PXFYD35330CL-YCW

3.5

330

中切雙面齒
Double Serrated-Lateral Cutting

33

PXFYD30330RCD-YCW

3

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

34

PXFYD30330CD-YCW

3

330

頂切雙面齒
Double Serrated-Top Cutting

35

PXFYD30330RCL-YCW

3

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

36

PXFYD30330CL-YCW

3

330

中切雙面齒
Double Serrated-Lateral Cutting

37

PXFYD25330RCD-YCW

2.5

330

頂切外刃內(nèi)齒
Single Serrated-Top Cutting

38

PXFYD25330CD-YCW

2.5

330

頂切雙面齒
Double Serrated-Top Cutting

39

PXFYD25330RCL-YCW

2.5

330

中切外刃內(nèi)齒
Single Serrated-Lateral Cutting

40

PXFYD25330CL-YCW

2.5

330

中切雙面齒
Double Serrated-Lateral Cutting





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