Wuhan HealthCare Biotechnology Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000033113

Devices: 187
Registrations: EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union: EUDAMED actor, 1 certificate

Catalogue187

Newest first, rows 1-50 of 187

Search and filter all 187 devices

Rows 1-50 of 187

Showing 1-50 of 187

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: [email protected]
PRRC contact: Jinling Fu(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next 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

Frequently asked questions

How many devices does Wuhan HealthCare Biotechnology Co., Ltd. have in the registry?

The registry currently lists 187 devices for Wuhan HealthCare Biotechnology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wuhan HealthCare Biotechnology Co., Ltd.'s devices?

Among its 50 most recently registered devices, Wuhan HealthCare Biotechnology Co., Ltd. has devices listed in EUDAMED (50 devices).

What risk classes do Wuhan HealthCare Biotechnology Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Wuhan HealthCare Biotechnology Co., Ltd.'s devices are IVDR Class A, IVDR Class C and IVD general. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Wuhan HealthCare Biotechnology Co., Ltd.?

EUDAMED lists 1 certificate for Wuhan HealthCare Biotechnology Co., Ltd. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 8 Sep 2026.

What are the newest devices from Wuhan HealthCare Biotechnology Co., Ltd. in the registry?

The most recently registered devices listed for Wuhan HealthCare Biotechnology Co., Ltd. include [IGH/CCND1]/[IGH/MAF]/[IGH/MAFB]/[IGH/FGFR3] gene fusion probe reagent, Fast Fluorescence In Situ Hybridization Probe Kit, Prenatal chromosomes probe detection kit and NTRK1/NTRK2/NTRK3 gene break apart probe reagent.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

EU certificates

Market reach

Catalogue187

[IGH/CCND1]/[IGH/MAF]/[IGH/MAFB]/[IGH/FGFR3] gene fusion probe reagent Ref FP-233-1

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-004

Prenatal chromosomes probe detection kit Ref FP-314

NTRK1/NTRK2/NTRK3 gene break apart probe reagent Ref FP-231-3

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-233-3

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-243-3

CLL chromosome and gene anomaly probe detection kit Ref FP-014-1

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-305-1

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-183

TERC gene amplification probe detection kit Ref FP-013

RARA (17q21) probe reagent Ref FP-005

TCF3/PBX1gene fusion probe reagent Ref FP-062

Bladder Cancer Cells chromosome and gene anomaly probe detection kit Ref FP-009

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-242-4

Chromosome 8 centromere probe reagent Ref FP-018-1

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-234-3

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-368

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-232-2

BCL6/MYC/IGH/[BCL2/IGH] gene probe reagent Ref FP-242-3

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-056

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-074

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-231-3

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-011-1

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-045

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-158

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-245-3

FGFR1/PDGFRA/PDGFRB gene break apart probe reagent Ref FP-232-1

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-018-2

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-181

p53/[CCND1/IGH]/ATM/CSP12/D13S25 gene probe reagent Ref FP-245-3

Washing Solution Ref CL-009-11

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-231-2

Chromosome 8 centromere probe reagent Ref FP-018-3

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-052

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-027

FGFR1/PDGFRA/PDGFRB gene break apart probe reagent Ref FP-232-2

BCL6/MYC/IGH/[BCL2/IGH] gene probe reagent Ref FP-242-4

SS18 (SYT) gene break apart probe reagent Ref FP-055

NTRK1/NTRK2/NTRK3 gene break apart probe reagent Ref FP-231-2

MDS chromosome and gene anomaly probe detection kit Ref FP-011-5

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-075

EVI gene break apart probe reagent Ref FP-179-1

MYC(8q24)/BCL6(3q27)/BCL2(18q21) gene break apart probe reagent Ref FP-243-2

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-018-3

1p/19q deletion probe reagent Ref FP-045

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-340

13 (13q14) probe reagent Ref FP-025

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-011-4

KMT2A (MLL) gene break apart probe reagent Ref FP-026

Fast Fluorescence In Situ Hybridization Probe Kit Ref FP-028

Company details

EUDAMED certificates1

TÜV SÜD Product Service GmbH 0123 ·1 certificate

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TÜV SÜD Product Service GmbH 0123 1 certificate