HomeChinaSOL‐MILLENNIUM MEDICAL HK LIMITED

SOL‐MILLENNIUM MEDICAL HK LIMITED

China · Hong Kong · www.solm.com
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
32listed device types
Class I 18Class II 13Class III 0unclassified 1
plus 57 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
26registered device records
Class I 14Class IIa 12
BRBrazilANVISA
2registered devices
Class I 2
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
5active device licences
Class II 5
38 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
16device registrations
CLASS B 16
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
22active ARTG entries
Class I 2IIa 16Class Is (sterile) 4
HKHong KongMDACS
12valid listings
Class II 12
ILIsraelAMAR
pendingnot queried
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 Union3,734 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States57 registration records, 16 510(k), 0 PMA, 9 excluded
United Kingdom26 confirmed, 2 excluded
Brazil2 confirmed, 3 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: Sol-Millennium Medical, Inc. · SOL-MILLENNIUM MEDICAL, INC. · SOL-MILLENNIUM BRASIL IMPORTACAO E EXPORTACAO LTDA · Shangai Sol-Millennium Medical Products Co. Ltd.

Regulatory identity

UK responsible person
Sol-Millennium UK Ltd

Company information

Country
China
City
Hong Kong
Website
www.solm.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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.

FDA 510(k) clearances by year

12012
12013
12014
22016
12017
12018
12021
22022
12023
32024
12025
12026

FDA listed device types

showing 8 of 32
Cap, Surgical 1Hearing Aid, Air-Conduction, Over The Counter 1Syringe, Irrigating (Non Dental) 1Gauze / Sponge,Nonresorbable For External Use 1Dispenser, Liquid Medication 1Accessory, Surgical Apparel 1Non-Surgical Gown 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
UK44127Pen NeedleClass IIa
UK65416SOL-CARE Safety Winged Infusion SetClass IIa
UK58497SOL-CARE Safety Blood Collection NeedleClass IIa
USK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18
USK250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set2025-04-30
USK242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle2024-11-20
BR80937150072SOL-M TAMPA PROTETORA LUER FÊMEAClass I
BR10369460080AGULHA DE SEGURANÇA LABOR IMPORT HIPODÉRMICAClass I
CA72589EZ WING VIAL ACCESS PLASTIC CANNULAClass II
CA72662LUER LOCK SYRINGES WITH EZ WING VIAL ACCESS CANNULAClass II
CA73483INVIRODRAWClass II

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