HomeChinaHunan Accurate Bio-Medical Technology Co.,Ltd

Hunan Accurate Bio-Medical Technology Co.,Ltd

China · 长沙 · www.accbiomed.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000012835Unified social credit code 914301000813947335

This company holds 8 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Hong Kong, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
8China registrations
Class II 8
as of 2026-09-04
EUEuropean UnionEUDAMED
144UDI-DI device records
Class I 11Class IIa 101Class IIb 32
USUnited StatesFDA openFDA
6listed device types
Class I 2Class II 4Class III 0
plus 9 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 3Class IIa 2Class IIb 1
BRBrazilANVISA
3registered devices
Class II 3
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
2active ARTG entries
IIa 1IIb 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 Union144 raw hits, 0 excluded, 144 confirmed
United States9 registration records, 6 510(k), 0 PMA, 7 excluded
China8 certificates (Class III 0 / II 8 / I 0), as of 2026-09-04
United Kingdom6 confirmed, 1 excluded
Brazil3 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. · HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000012835
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Etheria Medical Ltd
Unified social credit code
914301000813947335
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
121
Annual revenue
RMB 100–500M
Website
www.accbiomed.com
Product categories
医用电子妇产及生殖医用耗材口腔

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
2013-11-08
Registered capital
CNY 60,000,000
Paid-in capital
CNY 60,000,000
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Professional technical services
Last approval date
2025-10-23
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

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.

FDA 510(k) clearances by year

12014 · K141105
12018 · K171241
12024 · K240808
12025 · K243049
22026 · K252601

FDA listed device types

Oximeter, Wellness 1Vibrator For Therapeutic Use, Genital 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1Irrigator, Powered Nasal 1Unit, Oral Irrigation 1

Registration details (sample)

MarketIdentifierNameClass / date
CN湘械注准20252210172盆底数据处理软件Class II
CN湘械注准20252070687经皮黄疸仪Class II
CN湘械注准20242140021电动喷雾洗鼻器Class II
CN湘械注准20232180414血氧胎心监测仪Class II
EU06927394503174Pulse OximeterClass IIa
EU06927394502580Pulse OximeterClass IIa
EU06927394503136Pulse OximeterClass IIa
EU06927394503129Pulse OximeterClass IIa
UK34040Fetal DopplerClass IIa
UK48010Nasal IrrigatorClass I
UK46624Pelvic Floor ExerciserClass I
USK252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)2026-05-14
USK252748Pelvic Floor Exerciser (PF01)2026-04-27
USK243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)2025-01-02
BR81313779003DOPPLER FETAL PORTATILClass II
BR81778819034Oxímetro de Pulso PortátilClass II
BR81778819035Oxímetro de PulsoClass II

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