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Shenzhen Delica Medical Equipment Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000022543 FEI 3006441164

Devices
12
Registrations
EUDAMEDFDA
FDA recalls
0

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
United States
FDA FEI
Authorised rep.
Shanghai International Holding Corp. GmbH(Europe)DE

Catalogue12

Newest first, rows 1-12 of 12

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  • Delica Ref EMS-9M1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Delica Ref A08XXXXX

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Delica Ref EMS-9F

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Transcranial Doppler Ultrasound System Ref /

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Transcranial Doppler Ultrasound System Ref /

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Delica Ref EMS-9M2

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Ems-9D Exp Ref /

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Multifunctional Vascular Ultrasound Ref /

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Transcranial Doppler Ultrasound System Ref /

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Transcranial Doppler Ultrasound System Ref /

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:IIa

  • Electroencephalograph (EEG) Ref /

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Ems-9D Pro Ref /

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

Rows 1-12 of 12

Company details

EUDAMED SRN
CN-MF-000022543
FDA FEI number
3006441164
DUNS number
544412009
EUDAMED status
Active
EUDAMED registered name
Shenzhen Delica Medical Equipment Co., Ltd.
Registered address
18F, Building B, High-tech park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming District, 518107, Shenzhen, China
PRRC contact
Terry Xiao(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 17 Oct 2029

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 049512 0025 Active

    Quality management system EU MDR

    Issued
    18 Oct 2024
    Expires
    17 Oct 2029

Frequently asked questions

How many devices does Shenzhen Delica Medical Equipment Co., Ltd. have in the registry?

The registry currently lists 12 devices for Shenzhen Delica Medical Equipment Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shenzhen Delica Medical Equipment Co., Ltd.'s devices?

Among its 12 most recently registered devices, Shenzhen Delica Medical Equipment Co., Ltd. has devices listed in EUDAMED (12 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Shenzhen Delica Medical Equipment Co., Ltd.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Shenzhen Delica Medical Equipment Co., Ltd.'s devices are Class IIa. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Shenzhen Delica Medical Equipment Co., Ltd.?

EUDAMED lists 1 certificate for Shenzhen Delica Medical Equipment Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 18 Oct 2024.

What are the newest devices from Shenzhen Delica Medical Equipment Co., Ltd. in the registry?

The most recently registered devices listed for Shenzhen Delica Medical Equipment Co., Ltd. include DELICA, Transcranial Doppler Ultrasound System, EMS-9D EXP and Multifunctional Vascular Ultrasound.

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