Huaiyin Medical Instruments Co., Ltd

Certificate C660579

Rev. 2Issued

Valid until: Dec 19, 2028

Certificate C660579 is a valid Quality management system issued to Huaiyin Medical Instruments Co., Ltd and registered in EUDAMED. Valid until December 19, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: C660579
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C6605792

Validity

Issued: Dec 19, 2023
Valid from: Dec 19, 2023
Valid until: Dec 19, 2028

Manufacturer

Manufacturer: Huaiyin Medical Instruments Co., Ltd
Manufacturer SRN: CN-MF-000003351
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

: Yes
: No
: No
: No
: Yes
: No
: No
: Yes
: Yes
: No
: No

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb8

8 scopes

Non-absorbable Surgical Suture With / Without Needle - Silk Braided Suture Intended for general soft tissue suturing and/or ligation, but not for cardiovascular and neurological tissues.
Class IIb
Non-absorbable Surgical Suture With / Without Needle - Polyester Braided Suture Intended for general soft tissue suturing and/or ligation, but not for cardiovascular and neurological tissues.
Class IIb
Non-absorbable Surgical Suture With / Without Needle - Nylon Suture Intended for general soft tissue suturing and/or ligation, but not for cardiovascular and neurological tissues.
Class IIb
Non-absorbable Surgical Suture With / Without Needle - Polypropylene Suture Intended for general soft tissue suturing and/or ligation, but not for cardiovascular and neurological tissues.
Class IIb
Thread size (EP): 0.3, 0.4, 0.5, 0.7, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7 Thread size (USP): 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0/T, 2-0, 0, 1, 2, 3, 4, 5 Thread length (cm): 20, 30, 45, 60, 70, 75, 90, 100, 120, 150, 200, 250, 300, 350 Needle Type: Round needle, Triangle needle, Rectangular pyramid type, Taper needle with short cutting point Needle Length (mm): 6, 8, 10, 11, 12, 13, 15, 16, 17, 18, 19, 20, 22, 24, 25, 26, 28, 30, 31, 35, 36, 37, 38, 39, 40, 44, 45, 48, 50, 53, 55, 60, 65, 70,
Class IIb
Thread size (EP): 0.5, 0.7, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7 Thread size (USP): 7-0, 6-0, 5-0, 4-0, 3-0, 2-0/T, 2-0, 0, 1, 2, 3, 4, 5 Thread length (cm): 20, 30, 45, 60, 70, 75, 90, 100, 120, 150, 200, 250, 300, 350 Needle Type: Round needle, Triangle needle, Rectangular pyramid type, Taper needle with short cutting point Needle Length (mm): 6, 8, 10, 11, 12, 13, 15, 16, 17, 18, 19, 20, 22, 24, 25, 26, 28, 30, 31, 35, 36, 37, 38, 39, 40, 44, 45, 48, 50, 53, 55, 60, 65, 70, 75, 80,
Class IIb
Thread size (EP): 0.2, 0.3, 0.4, 0.5, 0.7, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5Thread size (USP): 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0/T, 2-0, 0, 1, 2 Thread length (cm): 20, 30, 45, 60, 70, 75, 90, 100, 120, 150, 200, 250, 300, 350 Needle Type: Round needle, Triangle needle, Rectangular pyramid type, Taper needle with short cutting point Needle Length (mm): 6, 8, 10, 11, 12, 13, 15,16, 17, 18, 19, 20, 22, 24, 25, 26, 28, 30, 31, 35,36, 37, 38, 39, 40, 44, 45, 48, 50, 53, 55, 60, 65, 70, 75, 80
Class IIb
Thread size (EP): 0.2, 0.3, 0.4, 0.5, 0.7, 1, 1.5,2, 2.5, 3, 3.5, 4, 5 Thread size (USP): 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0/T, 2-0, 0, 1, 2 Thread length (cm): 20, 30, 45, 60, 70, 75, 90, 100, 120, 150, 200, 250, 300, 350 Needle Type: Round needle, Triangle needle, Rectangular pyramid type, Taper needle with short cutting point Needle Length (mm): 6, 8, 10, 11, 12, 13, 15, 16, 17, 18, 19, 20, 22, 24, 25, 26, 28, 30, 31, 35, 36, 37, 38, 39, 40, 44, 45, 48, 50, 53, 55, 60, 65, 70, 75,
Class IIb

Documents

LanguagesEN