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Sunkiss Healthcare Co., Ltd.

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000034778Unified social credit code 913301005551720254

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Israel — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

12China registrations

Class I 4

as of 2026-09-04

EUEuropean UnionEUDAMED

71UDI-DI device records

Class I 71

USUnited StatesFDA openFDA

6listed device types

Class I 5Class II 0Class III 0unclassified 1

plus 6 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 3

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union71 raw hits, 0 excluded, 71 confirmed

United States6 registration records, 0 510(k), 0 PMA

China12 certificates (Class III 0 / II 0 / I 4), as of 2026-09-04

United Kingdom3 confirmed, 0 excluded

Manufacturer names merged into this page: SUNKISS HEALTHCARE(ZHEJIANG) CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000034778
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 913301005551720254
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2010-06-01
Registered capital: USD 10,000,000
Paid-in capital: USD 10,000,000
Legal form: Limited liability company (Sino-foreign joint venture)
Industry classification: Paper and paper products
Last approval date: 2020-02-23
Recognitions: National High-Tech EnterpriseTechnology-based SMESRDI SMERecognised enterprise technology centreInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua 1Pad, Menstrual, Unscented 1Garment, Protective, For Incontinence 1Accessory, Surgical Apparel 1Suit, Surgical 1Disinfectant, Medical Devices 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙杭械备20200077号	隔离衣	Class I · 2020-02-21
CN	浙杭械备20210308号	医用垫单	Class I
CN	浙杭械备20210124号	棉片	Class I
CN	浙杭械备20170360号	医用护理垫（看护垫）	Class I
EU	06971155846734	—	Class I
EU	06971155847458	—	Class I
EU	06971155847441	—	Class I
EU	06971155847434	—	Class I
UK	61850	Adult Diapers	Class I
UK	11239	Adult Diapers	Class I
UK	35817	Incontinence Pads	Class I

Sunkiss Healthcare Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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