Romsons International (Unit II)

Certificate C627052

Rev. 0Issued

Valid until: Oct 10, 2028

Certificate C627052 is a valid Quality assurance issued to Romsons International (Unit II) and registered in EUDAMED. Valid until October 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: C627052
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C6270520

Validity

Issued: Oct 10, 2023
Valid from: Oct 10, 2023
Valid until: Oct 10, 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: Yes
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 IIa10

10 scopes

Urethral Catheter
Class IIa
3-Way Stopcock
Class IIa
I.V. Cannula
Class IIa
Suction Catheter
Class IIa
Infusion Set with & without needle
Class IIa
Brand: Nel Cath, Urocath-2 Way & 3 Way FoleyTrac, Foley Catheter Model: GS 1004 & 1004F, GS1072 & GS1094, GS1026, GS1108 Size: FG-06, 08,10,12,14, 16, 18, 20, 22, 24
Class IIa
Brand: BI-VALVE, EXXACTA, EXXACTA MARVEL, Three Way Stop Cock Model: GS-3040, GS-3146, GS-3150, GS-3164 Size: Standard
Class IIa
Brand: IntraCath-2, Intraflon, VeinCath, Venican, Intracan, Intravein, Vennula, Veneport, Intrasafe, Venesafe, Brand: Kenzocath, Brand: Triflon, Brand: Neocath-2, Neocath, Neocare, Brand: Micron, Brand: Romsons Model: GS- 3162,Model: GS- 3160,Model: GS- 3158, Model: GS- 3166
Class IIa
Brand: Suction Catheter - Plain, Suction Catheter - TC, Suction Catheter - TS, Suction Catheter - FT Model: GS 2006, GS 2030, GS 2030TS, GS 2022 Size: FG-05, 06, 08, 10, 12, 14, 16, 18
Class IIa
Burette Infusion: Brand (all with & without needle): Volumetric Set, Volumetric plus, Volufix, Volufix plus, Buretta, Measured volume Infusion Set, Infusion set: Brand: RMS Vented Infusion Set (w/o needle), RMS Infusion Set (w/o needle), Inflow Set- Vented Infusion Set (w & w/o needle), Intracare (w & w/o needle), Romotrol (w & w/o needle), Transflow (w & w/o needle), Microperf, Steri Set (w & w/o needle), Steri Flo (w & w/o Needle), Steri Flo plus (w & w/o needle), Rota Flo (w & w/o needle),
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa10

10 scopes

Urethral Catheter
Class IIa
3-Way Stopcock
Class IIa
I.V. Cannula
Class IIa
Suction Catheter
Class IIa
Infusion Set with & without needle
Class IIa
Brand: Nel Cath, Urocath-2 Way & 3 Way FoleyTrac, Foley Catheter Model: GS 1004 & 1004F, GS1072 & GS1094, GS1026, GS1108 Size: FG-06, 08,10,12,14, 16, 18, 20, 22, 24
Class IIa
Brand: BI-VALVE, EXXACTA, EXXACTA MARVEL, Three Way Stop Cock Model: GS-3040, GS-3146, GS-3150, GS-3164 Size: Standard
Class IIa
Brand: IntraCath-2, Intraflon, VeinCath, Venican, Intracan, Intravein, Vennula, Veneport, Intrasafe, Venesafe, Brand: Kenzocath, Brand: Triflon, Brand: Neocath-2, Neocath, Neocare, Brand: Micron, Brand: Romsons Model: GS- 3162,Model: GS- 3160,Model: GS- 3158, Model: GS- 3166
Class IIa
Brand: Suction Catheter - Plain, Suction Catheter - TC, Suction Catheter - TS, Suction Catheter - FT Model: GS 2006, GS 2030, GS 2030TS, GS 2022 Size: FG-05, 06, 08, 10, 12, 14, 16, 18
Class IIa
Burette Infusion: Brand (all with & without needle): Volumetric Set, Volumetric plus, Volufix, Volufix plus, Buretta, Measured volume Infusion Set, Infusion set: Brand: RMS Vented Infusion Set (w/o needle), RMS Infusion Set (w/o needle), Inflow Set- Vented Infusion Set (w & w/o needle), Intracare (w & w/o needle), Romotrol (w & w/o needle), Transflow (w & w/o needle), Microperf, Steri Set (w & w/o needle), Steri Flo (w & w/o Needle), Steri Flo plus (w & w/o needle), Rota Flo (w & w/o needle),
Class IIa

Certificate C627052

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate C627052

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer