HomeNEOMED CO.,LTD

NEOMED CO.,LTD

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Taiwan — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
16listed device types
Class I 15Class II 0Class III 0unclassified 1
plus 16 registration records and 17 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 Union138 raw hits, 138 excluded, 0 confirmed
United States16 registration records, 17 510(k), 0 PMA
United Kingdom0 confirmed, 1 excluded
Saudi Arabia8 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: NEOMED CO., LTD. · Neomed · Neomed Co., Ltd.

Regulatory identity

Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

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

21978
11979
11989
12007
42008
22010
22012
22015
12016
12019

FDA listed device types

showing 8 of 16
Pad, Eye 1Orthosis, Limb Brace 1Orthosis, Lumbar 1Orthosis, Abdominal 1Pack, Hot Or Cold, Disposable 1Splint, Clavicle 1Sling, Arm 1Head Halter, Traction 1

Registration details (sample)

MarketIdentifierNameClass / date
USK183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)2019-04-30
USK161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)2016-06-17
USK152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps2015-12-17
SAME0000022224SFDAA00001Neo Back Support
SAME0000022277SFDAA00001Neomed

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