Romsons International (Unit II)

Certificate 10000507726-PA-NoMA-IND

Rev. 0Issued

Valid until: Apr 27, 2028

Certificate 10000507726-PA-NoMA-IND is a valid Quality assurance issued to Romsons International (Unit II) and registered in EUDAMED. Valid until April 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000507726-PA-NoMA-IND
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000507726-PA-NoMA-IND0

Validity

Issued: Apr 28, 2023
Valid from: Apr 28, 2023
Valid until: Apr 27, 2028

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I18

18 scopes

Umbilical Cord Clamp
Class I
Mid-Stream Urine Collection Set
Class I
Bile Collection Bag
Class I
Urine Collection Bags
Class I
Measured Volume Chamber with Urine Collection Bag
Class I
Brand: Klik Clamp Model: GS-5084
Class I
1.Brand: Romsons Mid-Stream Urine Collection Set Model: GS 252, GS 257, GS 260 Size:20ml
Class I
2.Brand: Universal Mid-Stream Urine Collection Set Model: UN 252, UN 257,UN 260 Size:20ml
Class I
1.Brand: Romsons Bile Bag Model: GS 5110,GS 5111 Size: 350ml, 500ml
Class I
2.Brand: Universal Bile Bag Model: UN400WB,UN400RK,UN405WB, UN405RK Size: 350ml, 500ml
Class I
1.Brand: UCB with NRV & Bottom Outlet, UCB with NRV & Bottom Outlet & Hanger, UCB with NRV & T-Tap Bottom Outlet, UCB with NRV & without Bottom Outlet, UCB without NRV & without Bottom, Outlet, UCB with NRV & without Bottom Outlet, UCB without NRV & without Bottom Outlet, UCB with NRV & T-Tap & Hanger, UCB with NRV & T-Tap Bottom Outlet Model: GS-1020A,GS-1020AH,GS-1020T, GS- 1020B, GS-1020C,GS-1020D,GS-1020E,GS-1020 R4,GS-1020 R5 Size: 1500ml, 2000ml
Class I
2.Brand:,Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet,Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet Model: GS-1024A,GS-1024B,GS-1024C,GS- 1024D,GS-1024E,GS-1024F Size: 500ml, 750ml
Class I
3.Brand: UCB with NRV Model:UN-40 Size: 1500ml, 2000ml
Class I
4.Brand: Paediatric Urine Collection Bag Model: GS-1062 Size: 100ml, 200ml
Class I
1.Brand: Urometer Model: GS 1018-100, Size:100ml Model: GS 1018-250, Size:250ml Model: GS 1018-500, Size:500ml Model: GS-1018-500E, Size:500ml
Class I
2.Brand:Measurexe Model: GS 1018M-500, Size:500ml
Class I
3.Brand:Spare bag for Urometer Model: GS 1018SB, Size:2000ml
Class I
4.Brand:Spare Bag for Measurexe Model: GS 1018MSB, Size:2000ml
Class I

Documents

LanguagesEN

Scope coverage

Class I18

18 scopes

Umbilical Cord Clamp
Class I
Mid-Stream Urine Collection Set
Class I
Bile Collection Bag
Class I
Urine Collection Bags
Class I
Measured Volume Chamber with Urine Collection Bag
Class I
Brand: Klik Clamp Model: GS-5084
Class I
1.Brand: Romsons Mid-Stream Urine Collection Set Model: GS 252, GS 257, GS 260 Size:20ml
Class I
2.Brand: Universal Mid-Stream Urine Collection Set Model: UN 252, UN 257,UN 260 Size:20ml
Class I
1.Brand: Romsons Bile Bag Model: GS 5110,GS 5111 Size: 350ml, 500ml
Class I
2.Brand: Universal Bile Bag Model: UN400WB,UN400RK,UN405WB, UN405RK Size: 350ml, 500ml
Class I
1.Brand: UCB with NRV & Bottom Outlet, UCB with NRV & Bottom Outlet & Hanger, UCB with NRV & T-Tap Bottom Outlet, UCB with NRV & without Bottom Outlet, UCB without NRV & without Bottom, Outlet, UCB with NRV & without Bottom Outlet, UCB without NRV & without Bottom Outlet, UCB with NRV & T-Tap & Hanger, UCB with NRV & T-Tap Bottom Outlet Model: GS-1020A,GS-1020AH,GS-1020T, GS- 1020B, GS-1020C,GS-1020D,GS-1020E,GS-1020 R4,GS-1020 R5 Size: 1500ml, 2000ml
Class I
2.Brand:,Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet,Leg Bag with NRV & T-Tap Bottom Outlet, Leg Bag with NRV & T-Tap Bottom Outlet Model: GS-1024A,GS-1024B,GS-1024C,GS- 1024D,GS-1024E,GS-1024F Size: 500ml, 750ml
Class I
3.Brand: UCB with NRV Model:UN-40 Size: 1500ml, 2000ml
Class I
4.Brand: Paediatric Urine Collection Bag Model: GS-1062 Size: 100ml, 200ml
Class I
1.Brand: Urometer Model: GS 1018-100, Size:100ml Model: GS 1018-250, Size:250ml Model: GS 1018-500, Size:500ml Model: GS-1018-500E, Size:500ml
Class I
2.Brand:Measurexe Model: GS 1018M-500, Size:500ml
Class I
3.Brand:Spare bag for Urometer Model: GS 1018SB, Size:2000ml
Class I
4.Brand:Spare Bag for Measurexe Model: GS 1018MSB, Size:2000ml
Class I

Certificate 10000507726-PA-NoMA-IND

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate 10000507726-PA-NoMA-IND

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer