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Cobes Industries (Hefei) Co., Ltd.

China · Anhui Hefei · www.cobeshk.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000012364Unified social credit code 913401226808485813

This company holds 31 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Taiwan, South Korea, Australia, Israel — 7 overseas markets. EU UDI-DI records ≥233, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

31China registrations

Class I 13Class II 18

as of 2026-09-04

EUEuropean UnionEUDAMED

≥233UDI-DI device records

Class I 216Class IIa 17

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

44registered device records

Class I 17System or Procedure Pack 27

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

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

11active ARTG entries

Class I 4Class Is (sterile) 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union986 raw hits, 67 excluded, 233 confirmed. Large result set — only the first 300 verified

United States0 registration records, 3 510(k), 0 PMA, 3 excluded

China31 certificates (Class III 0 / II 18 / I 13), as of 2026-09-04

United Kingdom44 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: CN-MF-000012364
EU authorised representative: Emergo Europe B.V.
UK responsible person: KINGSMEAD SERVICE LIMITED
Unified social credit code: 913401226808485813
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2008-11-04
Registered capital: CNY 28,243,354
Paid-in capital: CNY 28,105,346
Legal form: Limited liability company
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-12-04
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SMERecognised enterprise technology centre

Business registration data from Tianyancha, as of 2026-09-02. 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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	皖械注准20252140287	一次性使用中单	Class II
CN	皖械注准20252140270	一次性使用穿刺针及附件	Class II
CN	皖械注准20252140008	一次性使用透析护理包	Class II
CN	皖械注准20242170034	一次性使用无菌口腔冲洗器	Class II
EU	06956288632225	Foliodress® Gown Soft Duo Reinforced XXL sterile	Class I
EU	06956288632164	Foliodress® Gown Soft Duo Reinforced XL sterile	Class I
EU	06956288632171	Foliodress® Gown Soft Duo Reinforced L sterile	Class I
EU	06956288683180	OPERO PLUS VELCRO TAPE 2,5 x 23 cm	Class I
UK	58934	Baby drape	Class I
UK	35492	Isolation Gown	Class I
UK	35492	Isolation Gown	Class I
US	K141606	SURGICAL GOWN	2014-11-17
US	K112796	SURGICAL GOWN (EO STERILIZED)	2013-09-12
US	K112378	COBES SURGICAL DRAPE	2012-05-08

Cobes Industries (Hefei) Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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