BIO-MED HEALTHCARE PRODUCTS PVT. LTD.

Certificate C546174

Rev. 0Issued

Valid until: Jul 9, 2031

Certificate C546174 is a valid Quality management system issued to BIO-MED HEALTHCARE PRODUCTS PVT. LTD. and registered in EUDAMED. Valid until July 9, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: C546174
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5461740

Validity

Issued: Jul 10, 2026
Valid from: Jul 10, 2026
Valid until: Jul 9, 2031

Manufacturer

Manufacturer: BIO-MED HEALTHCARE PRODUCTS PVT. LTD.
Manufacturer SRN: IN-MF-000016905
Manufacturer country: India

Notified body

Notified body
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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa12Class I2

14 scopes

Sterile Hypodermic Single Use Syringe with Needles
Class IIa
Sterile Hypodermic Single Use Needles
Class IIa
Sterile Hypodermic Single Use Insulin Syringes with Needle
Class IIa
Infusion Set (I.V. Set) with Needle
Class IIa
Blood Administration Set with Needle
Class IIa
Endotracheal Tube
Class IIa
Sterile Hypodermic Single Use Syringe without Needle
Class I
Brands: Bio-Med, Mr. Inject, Procare, Medicare, HEMC, ANGELTOUCH, K (KRAPE), MEDILIFE, NET, Health, SANBAO, Vacci-INJECT, VitalGold, NeoJect, BEGOTEK, Maxima Size: 0.5 ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 50ml
Class IIa
Brands: Bio-Med, Mr. Inject, NET, JRZ+, Medrop, 2MM, VitalGold, BEGOTEK , Maxima Size: 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G
Class IIa
Brands: Bio-Med, Mr. Inject, Procare, HE, HM HEALTHCARE, NET, ANGELTOUCH, Health, MEDIPLUS, ANGIPLAST, MEDICARE, DEMOTEK, VitelGold, BEGOTEK, Maxima Size: 40 Units & 100 Units
Class IIa
Brands: Bio-Med, MEDILIFE, NET, KINGS, Health, TOP CARE, 2MM, BEGOTEK , Maxima, Star, GMC Variants: I.V. Set with or without Air vent, Micro I.V. Set, I.V. Set with flow regulator, I.V. Set with 3-Way Stop Cock, Measure Volume Administration Set (Pediatric / Burette Set-100 ML, 110 ML, 150 ML)
Class IIa
Brands: Bio-Med,MEDILIFE, NET, Health, BEGOTEK, Maxima Variant: Blood Transfusion/Giving Set Vented/Non- Vented
Class IIa
Brand: Bio-Med Variant: Endotracheal Tube Cuffed Size:- 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10 Variant: Endotracheal Tube without Cuffed (Plain) Size:- 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10
Class IIa
Brands: Bio-Med, Mr. Inject, Procare, Medicare, HEMC, ANGELTOUCH, K (KRAPE), MEDILIFE, NET, Health, SANBAO, Vacci-INJECT, VitalGold, NeoJect, BEGOTEK, Maxima Size: 0.5 ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 50ml
Class I

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