Wuhan HealthCare Biotechnology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000033113
- Devices
- 187
- Registrations
- EUDAMED
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
13q probe reagent Ref FP-305-1
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
CDK4 (12q13)/SE12 probe reagent Ref FP-149
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralEWSR1 gene break apart probe reagent Ref FP-051
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-011-6
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
RET (10q11) gene break apart probe reagent Ref FP-059
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralChromosome 8 centromere probe reagent Ref FP-018-2
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General20q deletion probe reagent Ref FP-020
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
MDS chromosome and gene anomaly probe detection kit Ref FP-011-7
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
MDS chromosome and gene anomaly probe detection kit Ref FP-011-6
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMDS chromosome and gene anomaly probe detection kit Ref FP-011-1
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCBFB gene break apart probe reagent Ref FP-027
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
Chromosome 12 centromere probe reagent Ref FP-034
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
CBFB/MYH11 gene fusion probe reagent Ref FP-028
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-018-1
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMYCN gene amplification probe reagent Ref FP-048
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMYB (6q23) gene probe reagent Ref FP-036
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-232-1
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
1q21 and 1p32 anomaly probe reagent Ref FP-197
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Fast Fluorescence In Situ Hybridization Probe Kit Ref CL-014-1
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:C
EVI gene break apart probe reagent Ref FP-179-2
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFast Fluorescence In Situ Hybridization Probe Kit Ref FP-011-5
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMDS chromosome and gene anomaly probe detection kit Ref FP-011-3
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCLL chromosome and gene anomaly probe detection kit Ref FP-014-2
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMDS chromosome and gene anomaly probe detection kit Ref FP-011-4
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
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Company details
- EUDAMED SRN
- CN-MF-000033113
- EUDAMED status
- Active
- EUDAMED registered name
- Wuhan HealthCare Biotechnology Co., Ltd.
- EUDAMED abbreviated name
- Wuhan HealthCare
- Registered address
- #9, Gaokeyuan 3rd. Road, 430206, Wuhan City, Hubei Province, China
- [email protected]
- PRRC contact
- Jinling Fu(public in EUDAMED)
EUDAMED certificates1
1 certificate·1 valid, 0 expired·IVDR 1·next expiry 27 Aug 2031
TÜV SÜD Product Service GmbH 0123 ·1 certificate
- V13 005021 0003 Active
Quality management system ·EU IVDR
- Issued
- 8 Sep 2026
- Expires
- 27 Aug 2031