HomeChinaGRI Medical & Electronic technology Co., Ltd

GRI Medical & Electronic technology Co., Ltd

China · 嘉兴 · www.alleset.cn
✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000004203Unified social credit code 913304007458363044

This company holds 31 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 10 overseas markets. EU UDI-DI records ≥42, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
31China registrations
Class II 24
as of 2026-09-04
EUEuropean UnionEUDAMED
≥42UDI-DI device records
Class I 41Class IIa 1
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
71listed device types
Class I 33Class II 37Class III 0unclassified 1
plus 89 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
46registered device records
Class I 38Class IIa 6System or Procedure Pack 2
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
9 including historic records
TWTaiwanTFDA
10valid device licences
Class I 8Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
83active ARTG entries
Class I 21IVD Class 1 1IIa 16IIb 11Class Is (sterile) 34
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
5registrations
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 Union4,336 raw hits, 258 excluded, 42 confirmed. Large result set — only the first 300 verified
United States89 registration records, 7 510(k), 0 PMA, 5 excluded
China31 certificates (Class III 0 / II 24 / I 0), as of 2026-09-04
United Kingdom46 confirmed, 14 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. · GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD · GRI Medical & Electronic Technology Co.,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000004203
EU authorised representative
Emergo Europe B.V.
UK responsible person
IMed Consultancy Ltd
Unified social credit code
913304007458363044
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
592
Annual revenue
over RMB 500M
Website
www.alleset.cn
Product categories
医用耗材体外诊断

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2003-02-12
Registered capital
USD 6,600,000
Paid-in capital
USD 6,600,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Other manufacturing
Last approval date
2024-11-20
Recognitions
National High-Tech EnterpriseRecognised enterprise technology centre

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 510(k) clearances by year

22011 · K111458
12016 · K162442
32017 · K172445
12018 · K172835

FDA listed device types

showing 8 of 71
Marker, Skin 1Gauze / Sponge,Nonresorbable For External Use 1Container, Specimen, Sterile 1Clamp 1Ear, Nose, And Throat Surgical Tray 1Bedding, Disposable, Medical 1Plastic Surgery And Accessories Kit 1Dressing, Wound, Occlusive 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20262140046一次性使用肠道冲洗袋Class II
CN浙械注准20252151412一次性病人转移垫组件Class II
CN浙械注准20252141754一次性使用引流袋Class II
CN浙械注准20252141442一次性使用灭菌橡胶外科手套Class II
EU16931918100272Class I
EU16931918107523Class I
EU16931918101477Class I
EU16942748435335Class I
UK61850UnderpadsClass I
UK47447Patient Warming Class I
UK61579Incision Device Class IIa
USK172835GRI-Alleset Veress Needle2018-06-11
USK172445RoyalGuard Surgical Gown, i600, Breathable2017-12-08
USK172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler2017-11-06
SAME0000011642SFDAA00003Ecolab

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →