HomeChinaSHANDONG ANDE HEALTHCARE APPARATUS CO. Ltd.

SHANDONG ANDE HEALTHCARE APPARATUS CO. Ltd.

China · Zibo Shandong · www.andehealthcare.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000011339Unified social credit code 91370300746575310A

This company holds 143 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Hong Kong, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥3, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
143China registrations
Class I 11Class II 27Class III 105
as of 2026-09-04
EUEuropean UnionEUDAMED
≥3UDI-DI device records
Class IIa 3
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
7listed device types
Class I 0Class II 7Class III 0
plus 7 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 2Class IIa 4
BRBrazilANVISA
55registered devices
Class I 10Class II 45
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
5active ARTG entries
IIa 1IIb 2Class Is (sterile) 2
HKHong KongMDACS
8valid listings
Class II 8
ILIsraelAMAR
21registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 Union12,499 raw hits, 97 excluded, 3 confirmed. Large result set — only the first 300 verified
United States7 registration records, 7 510(k), 0 PMA
China143 certificates (Class III 105 / II 27 / I 11), as of 2026-09-04
United Kingdom6 confirmed, 24 excluded
Brazil55 confirmed, 0 excluded
Manufacturer names merged into this page: Shandong Ande Healthcare Apparatus Co., Ltd. · SHANDONG ANDE HEALTHCARE APPARATUS CO., LTD. · Shinva Ande Healthcare Apparatus Co. Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000011339
EU authorised representative
MedNet EC-REP GmbH
UK responsible person
Medimap Ltd
Unified social credit code
91370300746575310A
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Zibo Shandong
Social-insurance enrolees
1,197
Annual revenue
over RMB 500M
Website
www.andehealthcare.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection controlDigital Medicine, Data & Artificial IntelligenceClinical workflow & decision support systems

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
2003-01-23
Registered capital
CNY 66,660,000
Paid-in capital
CNY 66,660,000
Legal form
Joint-stock limited company (foreign-invested)
Industry classification
Pharmaceutical manufacturing
Last approval date
2022-06-01
Recognitions
National High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centreTorch Programme enterpriseAbove-designated-size industrial enterprise

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

12017 · K162601
12020 · K193657
12021 · K202060
32022 · K201460
12024 · K222766

FDA listed device types

Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Syringe, Antistick 1Enteral Syringes With Enteral Specific Connectors 1Set, Administration, Intravascular 1Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263141056植入式给药装置Class III
CN国械注准20263071650一次性使用有创血压传感器Class III
CN国械注准20263031364外周球囊扩张导管Class III
CN国械注准20263030366颅内血栓抽吸导管Class III
EU16941512104910Class IIa
EU16941512104927Class IIa
EU16941512104903Class IIa
UK31336Arterial Blood SamplersClass IIa
UK12170Disposable Extension SetsClass IIa
UK63390Closed System Transfer Devices for Single UseClass I
USK222766Disposable Extension Set2024-04-12
USK201460Closed System Transfer Device2022-11-23
USK220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization2022-10-07
BR81840540008SAFE QUIMIO TRANSFERClass I
BR81472689021CANULA DE HUBER EXACT EASYClass II
BR81840549034SAFE QUIMIO TRANSFER - CONECTOR DE SERINGA SENSINOVClass I

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