Sml Genetree Co. Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000034755 FEI 3017485950
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
NamuPlex™ Ref GNT-2016-1
Regimes: CE IVDD Registry: EUDAMEDNamuPlex™ Ref Q021A-100
Regimes: CE IVDR Registry: EUDAMEDNamuPlex™ Ref GNT-2013-1
Regimes: CE IVDR Registry: EUDAMEDNamuPlex™ Ref GNT-2006-1
Regimes: CE IVDD Registry: EUDAMEDNamuPlex™ Ref Q023A-100
Regimes: CE IVDR Registry: EUDAMEDNamuPlex™ Ref Q022A-100
Regimes: CE IVDR Registry: EUDAMEDNamuPlex™ Ref Q005A-100
Regimes: CE IVDR Registry: EUDAMEDNamuPlex™ Ref Q024A-100
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000034755
- FDA FEI number
- 3017485950
- EUDAMED status
- Active
- EUDAMED registered name
- SML Genetree Co., Ltd.
- EUDAMED abbreviated name
- SML Genetree Co., Ltd
- Registered address
- 167, Songpa-daero, Songpa-gu, 05855, Seoul, South Korea
- Website
- genetree.co.kr
- [email protected]
- Phone
- +82 70 2057 7900
- PRRC contact
- Woo Hwang
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 18 May 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 795087 Active
Quality management system EU IVDR
- Issued
- 2 Jun 2026
- Expires
- 18 May 2030
- Reason
- Add device or group
Frequently asked questions
How many devices does SML GENETREE CO. LTD. have in the registry?
The registry currently lists 8 devices for SML GENETREE CO. LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SML GENETREE CO. LTD.'s devices?
Among its 8 most recently registered devices, SML GENETREE CO. LTD. has devices listed in EUDAMED (8 devices).
What risk classes do SML GENETREE CO. LTD.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for SML GENETREE CO. LTD.'s devices are IVDR Class B, IVDR Class C and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SML GENETREE CO. LTD.?
EUDAMED lists 1 certificate for SML GENETREE CO. LTD. (quality management system) under IVDR. The most recent was issued on 2 Jun 2026.
What are the newest devices from SML GENETREE CO. LTD. in the registry?
The most recently registered devices listed for SML GENETREE CO. LTD. include NamuPlex™.