5femnzh
Fiscal Year 2020
CERTIFICATION OF REGISTRATION
This certifies that:
HENAN JOINKONA MEDICAL PRODUCTS STOCK CO.,LTD
Xinxing Road, The South of Industry District, Lushan County,
Pingdingshan, HENAN, 467300, CHINA
has completed the FDA Establishment Registration and Device Listing with the US Food & Drug
Administration, through
Shenzhen CTB Testing Technology Co., Ltd.
Owner/Operator Number: 10062713
Device Listing#: See annex
CTB will confirm that such registration remains effective upon request and presentation of this certificate
until the end of the calendar year stated above, unless said registration is terminated after issuance of this
certificate. CTB makes no other representations or warranties, nor does this certificate make any
representations or warranties to any person or entity other than the named certificate holder, for whose sole
benefit it is issued. This certificate does not denote endorsement or approval of the certificate-holder’s device or
establishment by the U.S. Food and Drug Administration. CTB assumes no liability to any person or entity in
connection with the foregoing.
Pursuant to 21 CFR 807.39, “Registration of a device establishment or assignment of a registration number
does not in any way denote approval of the establishment or its products. Any representation that creates an
impression of official approval because of registration or possession of a registration number is misleading and
constitutes misbranding.” The U.S. Food and Drug Administration does not issue a certificate of registration,
nor does the U.S. Food and Drug Administration recognize a certificate of registration, CTB is not affiliated
with the U.S. Food and Drug Administration.
_________________
Chief engineer
Issued: March 4, 2020
Expiration Date: December 31, 2020
Fiscal Year 2020
CERTIFICATION OF REGISTRATION
Annex to Device Listing# for Owner/Operator Number: 10062713
Proprietary
Listing No. Code Device Name Activities
Names
INSTRUMENT, FEMALE SS
MANUAL, 3.5MM PELLET
D373299 MDM
SURGICAL, INSERTION
GENERAL USE TRAY
Kit, surgical
D373300 KDD instrument, Surgical Set
disposable
D373303 FYE DRESS, SURGICAL Surgical Gown Manufacturer
Contract
BEDDING, Manufacturer
D373304 KME DISPOSABLE, Surgical Drape Contract Sterilizer
MEDICAL Repackager/Relabeler
COVER, MATTRESS Remanufacturer
D373305 FMW (MEDICAL Tube Cover Foreign Exporter
PURPOSES)
FILTERS, CELL
COLLECTION, Liquid Collection
D373306 KET
TISSUE Pouch
PROCESSING
HELMET, Warm Blanket and
D373307 FXZ
SURGICAL Surgical Hood
NOT END OF THE ANNEX
Fiscal Year 2020
CERTIFICATION OF REGISTRATION
Annex to Device Listing# for Owner/Operator Number: 10062713
Proprietary
Listing No. Code Device Name Activities
Names
Non-surgical isolation Manufacturer
D373308 OEA Isolation Gown
gown Contract
Shield, protective, Protective Manufacturer
D373309 KPY Contract Sterilizer
personnel Coverall
Repackager/Relabeler
PACK, HOT OR
Remanufacturer
D373310 IMD COLD, Dressing Pack
Foreign Exporter
DISPOSABLE
END OF THE ANNEX
_________________
Chief engineer
Issued: March 4, 2020
Expiration Date: December 31, 2020
