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Polybell (Guangzhou) Limited

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000045579 FEI 3008711096

Devices
15
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
SUNGO Europe B.V.NL

What Polybell (Guangzhou) Limited makes

Polybell (Guangzhou) Limited manufactures nasal aspirators, which are single-use devices designed to clear mucus and secretions from an infant’s nose.

The company’s nasal aspirators are classified as Class I medical devices and are listed in the EU’s eudamed registry. The manufacturer is based in China.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue15

Newest first, rows 1-15 of 15

Search and filter all 15 devices
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  • Fatone BH627

    None Registry: GUDID Class:II
  • Fatone BH628

    None Registry: GUDID Class:II
  • Fatone BH707

    None Registry: GUDID Class:II
  • Fatone BH709

    None Registry: GUDID Class:II
  • Fatone BH110

    None Registry: GUDID Class:II
  • Fatone BH816

    None Registry: GUDID Class:II
  • Fatone BH813

    None Registry: GUDID Class:II
  • Fatone H701

    None Registry: GUDID Class:II
  • Fatone H1129

    None Registry: GUDID Class:II
  • Fatone H1128

    None Registry: GUDID Class:II
  • Fatone H620

    None Registry: GUDID Class:II
  • Fatone H705

    None Registry: GUDID Class:II
  • Fatone H706

    None Registry: GUDID Class:II
  • Electric Breast Pump (BH627) Ref K260346

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Nasal Aspirator Ref BPE 093

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-15 of 15

Company details

EUDAMED SRN
CN-MF-000045579
FDA FEI number
3008711096
DUNS number
545905049
EUDAMED status
Active
EUDAMED registered name
POLYBELL (GUANGZHOU) LIMITED
Registered address
No. 50, Xihu West Street, Renhe Town,, 510475, Guangzhou, Guangdong, China
PRRC contact
XU JACK(public in EUDAMED)

Frequently asked questions

How many devices does POLYBELL (GUANGZHOU) LIMITED have in the registry?

The registry currently lists 15 devices for POLYBELL (GUANGZHOU) LIMITED. Devices recorded under merged duplicate company entries are counted once.

Which registries list POLYBELL (GUANGZHOU) LIMITED's devices?

Among its 15 most recently registered devices, POLYBELL (GUANGZHOU) LIMITED has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do POLYBELL (GUANGZHOU) LIMITED's devices fall under?

Among its 15 most recently registered devices, the classes recorded for POLYBELL (GUANGZHOU) LIMITED's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from POLYBELL (GUANGZHOU) LIMITED in the registry?

The most recently registered devices listed for POLYBELL (GUANGZHOU) LIMITED include Fatone BH627, Fatone BH628, Fatone BH707 and Fatone BH709.

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