D E L A R A T I O N OF C O N F O R M I T Y

Dated: July 23, 2024

We:

Sar Sons Surgical PVT LTD,

Abdullah Steet,
Ugoki Road, Adalat Garh
Sialkot-Pakistan

Declare under our sole responsibility that that the product(s)

Surgical Instruments, Stainless Steel,

To which this declaration related is in conformity with the following standard(s) or other normative
document(s)

ISO 9001:2008 Quality Management Systems

ISO 13485:2003 Medical Devices-Quality Management Systems-Requirements for

Regulatory Purpose

ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices

ISO 17664:2004 Sterilization of Medical Devices-Information to be provided by the
manufacturer for the processing of re-sterilizable medical devices

EN 980:2008 Graphical Symbols for Use in the Labeling of Medical Devices

cGMP Medical Devices; Current Good Manufacturing Practice

93/42/EEC Council Directive for Medical Devices

ASTM-F899-09 Standard Specification for Stainless Steel Billet, Bar, and Wire for
Surgical Instruments

ISO 7153-1 Surgical Instruments – Metallic Materials – Part 1: Stainless Steel

Following all the provisions of Council Directive 93/42/EEC updated directive 2007/47/EEC under Rule 6
and according to annex V

COTTON
Scalpel haemostatic GYNECOLO SWAP
handles Scissors Forceps forceps GY forceps FORCEPS Tissue and intestinal

BI 020 01 CI 032 01 PI 295 01 PI 342 01 PI 336 01 PI 376 01 PI 383 01

BI 020 02 CI 032 02 PI 295 02 PI 342 02 PI 336 02 PI 376 02 PI 383 02

BI 020 09 CI 032 03 PI 295 03 PI 342 03 PI 336 03 PI 376 03 PI 383 03

BI 020 03 CI 032 04 PI 295 04 PI 342 04 PI 336 04 PI 376 04 PI 383 04

BI 020 04 CI 032 05 PI 295 05 PI 342 05 PI 336 05 PI 376 05 PI 384 01

BI 020 10 CI 032 06 PI 295 06 PI 342 06 PI 336 06 PI 376 06 PI 384 02

BI 020 11 CI 032 07 PI 295 07 PI 342 07 PI 337 01 PI 376 07 PI 384 03

Bi 020 05 CI 032 08 PI 295 08 PI 342 08 PI 337 02 PI 377 01 PI 384 04

Bi 020 06 CI 032 09 PI 295 09 PI 342 09 PI 337 03 PI 377 02 PI 384 05

Bi 020 07 CI 032 10 PI 295 10 PI 342 10 PI 337 04 PI 377 03 PI 385 01

CI 032 11 PI 295 11 PI 345 01 PI 337 05 PI 377 04 PI 385 02

Instruments
tray /
Containers CI 032 12 PI 295 12 PI 345 02 PI 338 01 PI 377 05 PI 385 03

CUB065 CI 032 13 PI 295 13 PI 345 03 PI 338 02 PI 377 06 PI 385 05

CUB075 CI 032 14 PI 295 14 PI 345 04 PI 338 03 PI 378 01 PI 385 06

CUB125 CI 032 15 PI 296 01 PI 349 01 PI 338 04 PI 378 02 PI 385 07

HARI20 CI 032 16 PI 296 02 PI 349 02 PI 339 01 PI 378 03 PI 385 08

HARI25 CI 032 17 PI 299 01 PI 349 03 PI 339 02 PI 378 04 PI 385 09

CLAP01 CI 032 18 PI 299 02 PI 349 04 PI 339 03 PI 379 01 PI 385 11

ST2824 CI 032 19 PI 299 03 PI 349 05 PI 339 04 PI 379 02 PI 385 12

ST3535 CI 032 20 PI 299 04 PI 349 06 PI 339 05 PI 379 03 PI 386 01

CUB100 CI 032 21 PI 299 05 PI 349 07 PI 339 06 PI 379 04 PI 386 02

CLAP04

CLAP03 CI 032 22 PI 299 06 PI 349 08 PI 339 07 PI 379 05 PI 386 04

 Needle
Holders CI 032 23 PI 299 07 PI 349 09 PI 340 01 PI 380 01 PI 386 05

PO 401 06 CI 032 24 PI 299 08 PI 349 10 PI 340 02 PI 380 02 PI 387 01

PO 401 07 CI 032 25 PI 299 09 PI 349 11 PI 340 03 PI 380 03 PI 387 02

PO 401 08 CI 032 26 PI 299 10 PI 349 12 PI 340 04 PI 380 04 PI 387 03

PO 401 09 CI 032 27 PI 299 11 PI 351 01 PI 365 01 PI 387 04

CI 032 28 PI 299 12 PI 351 02 PI 365 02 PI 387 05

Curettes CI 032 29 PI 299 13 PI 351 03 PI 365 03 PI 387 06

CU 148 02 CI 032 30 PI 299 14 PI 351 04 PI 365 04 PI 387 07

CI 033 01 PI 299 15 PI 351 05 PI 365 08 PI 389 01

CI 033 02 PI 299 16 PI 351 06 PI 389 02

Trachea
tubes CI 033 03 PI 299 17 PI 351 07 PI 389 03

TCCJ05 CI 033 04 PI 299 18 PI 351 08 PI 389 04

TCCJ06 CI 033 05 PI 299 19 PI 352 03 PI 389 05

TCCJ11 CI 033 06 PI 299 20 PI 352 04 PI 389 06

TCCJ12 CI 033 07 PI 300 01 PI 353 01 PI 389 07

CI 033 08 PI 300 02 PI 353 02 PI 390 01

CI 033 09 PI 300 03 PI 353 03 PI 390 02

CI 033 10 PI 300 04 PI 353 04 Cannulas PI 390 03

CI 033 11 PI 300 05 PI 353 05 HY 255 01 PI 390 04

Towel
CI 033 12 PI 300 06 PI 353 06 forceps CI 046 01

CI 033 13 PI 300 07 PI 353 07 PI 284 01 CA 026 03

CI 033 14 PI 300 08 PI 353 08 PI 284 02 CA 026 04

CI 033 15 PI 300 09 PI 353 09 PI 284 03 CA 026 05

CI 033 16 PI 300 10 PI 353 10 PI 284 04 CA 026 06

CI 033 17 PI 300 11 PI 354 01 PI 284 05 CA 026 07

CI 033 18 PI 300 12 PI 354 02 PI 284 06 CA 026 08

CI 034 01 PI 300 13 PI 354 03 PI 284 07 CA 027 01

CI 034 02 PI 301 01 PI 354 04 PI 285 01 CA 027 02

CI 034 03 PI 301 02 PI 354 05 PI 285 02 CA 027 03

CI 034 04 PI 301 03 PI 354 06 PI 285 03 CA 027 04

CI 034 07 PI 301 04 PI 354 07 PI 285 04 CA 027 05

Dissecting
CI 034 08 PI 301 05 PI 354 08 Forceps CA 027 06

CI 035 01 PI 301 06 PI 354 09 PA 266 01 CA 027 07

CI 035 02 PI 301 07 PI 354 10 PA 266 02 CA 027 08

CI 035 03 PI 301 08 PI 355 01 PA 266 03 CA 027 09

CI 035 04 PI 301 09 PI 355 02 PA 266 04 CA 027 10

CI 035 05 PI 301 10 PI 355 03 PA 266 05 CA 027 11

CI 035 06 PI 301 11 PI 355 04 PA 266 06 CA 027 12

CI 035 15 PI 301 12 PI 355 05 PA 266 07 CA 027 13

CI 035 16 PI 301 13 PI 355 06 PA 266 08 CA 027 14

CI 036 01 PI 301 14 PI 355 07 PA 266 09 CA 027 15

CI 036 02 PI 301 15 PI 355 08 PA 267 01 CA 027 16

CI 036 03 PI 301 16 PI 355 09 PA 267 02 CA 027 17

CI 036 04 PI 301 17 PI 355 10 PA 267 03 CA 027 18

CI 036 05 PI 302 01 PI 355 11 PA 267 04 CA 027 19

CI 036 06 PI 302 02 PI 355 12 PA 267 05 CA 027 20

CI 036 09 PI 302 03 PI 355 13 PA 267 06 CA 027 21

CI 036 10 PI 302 04 PI 355 14 PA 267 07 CA 027 22

CI 037 01 PI 302 05 PI 356 01 PA 267 08 CA 027 23

CI 037 02 PI 302 06 PI 356 02 PA 267 09 CA 027 24

CI 037 03 PI 302 07 PI 356 03 PA 267 10 CA 027 25

CI 037 04 PI 302 08 PI 356 04 PA 267 11 CA 027 26

CI 037 09 PI 302 09 PA 267 12 CA 027 27

CI 037 10 PI 302 10 PA 267 13 CA 027 28

CI 039 01 PI 307 01 PA 267 14

CI 039 02 PI 307 02 PA 269 01

CI 039 03 PI 307 03 PA 269 02

CI 039 04 PI 307 04 PA 269 03

CI 039 05 PI 307 05 PA 269 04

CI 039 06 PI 307 06 PA 269 05

CI 039 07 PI 309 01 PA 269 06

CI 039 08 PI 309 02 PA 269 07

CI 039 09 PI 309 03 PA 269 08

CI 039 10 PI 309 04 PA 269 09

CI 039 11 PI 309 05 PA 269 10

CI 039 12 PI 309 06 PA 271 01

CI 039 13 PI 309 07 PA 271 02

CI 039 14 PI 309 08 PA 271 03

CI 039 15 PI 309 09 PA 271 04

CI 039 16 PI 309 10 PA 271 05

CI 040 01 PI 309 11 PA 271 06

CI 040 02 PI 309 12 PA 271 07

CI 040 03 PI 309 13 PA 271 08

CI 040 04 PI 309 14 PA 271 09

CI 040 05 PI 309 15 PA 271 10

CI 040 06 PI 309 16 PA 271 11

CI 040 07 PI 309 19 PA 271 12

CI 041 01 PI 309 20 PA 271 13

CI 041 02 PI 309 21 PA 271 14

CI 041 03 PI 309 22 PA 272 01

CI 041 04 PI 309 23 PA 272 02

CI 041 05 PI 309 24 PA 272 03

CI 041 06 PI 309 25 PA 272 04

CI 041 07 PI 309 26 PA 272 05

CI 041 08 PI 309 27 PA 272 06

CI 041 09 PI 309 28

CI 041 10 PI 309 29

CI 041 11 PI 309 30

CI 046 01 PI 309 31
PI 309 32

PI 309 33

PI 309 34
PI 309 35

PI 309 36

PI 309 37

PI 309 38
PI 309 39

PI 309 40

___________________

QA Manager