HLB Life Science Co., LTD
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000031817 FEI 3016748351
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- CMC Medical Devices & Drugs SLES
Catalogue
Inverted cup 61mm(Blue) Ref HLB-ICTB61MM-25A
Regimes: CE IVDR Registry: EUDAMEDFixed Volume Dropper 300ul Ref HLB-FVD300UL-1A
Regimes: CE IVDR Registry: EUDAMEDMini-tip QP type 10ul (with plunger) Ref HLB-MNTQP10UL-1A
Regimes: CE IVDR Registry: EUDAMEDMini-tip Q type 20ul – Hydrophilic(Blue, Neck STR) Ref HLB-MNTQ20ULHBNS-25A
Regimes: CE IVDR Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
Mini-tip 10ul(non-heparin, with plunger) Ref HLB-MNT10UL-1A
Regimes: CE IVDR Registry: EUDAMEDCapillary tube 10/20ul (Blue/Black, 2 line) Ref HLB-CBT-1020UL-1A
Regimes: CE IVDR Registry: EUDAMEDMini-tip 10ul(non-heparin, with plunger) Ref HLB-MNT10UL-25A
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000031817
- FDA FEI number
- 3016748351
- EU VAT number
- 116-81-69278
- EUDAMED status
- Active
- EUDAMED registered name
- HLB Life Science Co., LTD
- Registered address
- 104, Yongmeorikeun-gil, Gongdo-eup, 17551, Anseong-si, Gyeonggi-do,, South Korea
- Website
- www.HLB-LS.com
- [email protected]
- Phone
- +82 31 658 8460
- PRRC contact
- Sang-woo Nam
Frequently asked questions
How many devices does HLB Life Science Co., LTD have in the registry?
The registry currently lists 8 devices for HLB Life Science Co., LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list HLB Life Science Co., LTD's devices?
Among its 8 most recently registered devices, HLB Life Science Co., LTD has devices listed in EUDAMED (7 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do HLB Life Science Co., LTD's devices fall under?
Among its 8 most recently registered devices, the classes recorded for HLB Life Science Co., LTD's devices are Class II and IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from HLB Life Science Co., LTD in the registry?
The most recently registered devices listed for HLB Life Science Co., LTD include Inverted cup 61mm(Blue), Fixed Volume Dropper 300ul, Mini-tip QP type 10ul (with plunger) and Mini-tip Q type 20ul – Hydrophilic(Blue, Neck STR).