HomeChinaZhejiang Longterm Medical Technology Co., Ltd.

Zhejiang Longterm Medical Technology Co., Ltd.

China · Deqing Zhejiang · www.longterm-health.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000001161

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel — 10 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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
≥300UDI-DI device records
Class I 40Class IIa 38Class IIb 222
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
26listed device types
Class I 23Class II 1Class III 0unclassified 2
plus 28 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
53registered device records
Class I 39Class IIa 2Class IIb 12
BRBrazilANVISA
29registered devices
Class I 20Class II 9
39 including historic records
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
33active ARTG entries
Class I 5IIa 2IIb 15Class Is (sterile) 11
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
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 Union1,372 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States28 registration records, 4 510(k), 0 PMA
United Kingdom53 confirmed, 0 excluded
Brazil29 confirmed, 0 excluded
Saudi Arabia7 confirmed, 0 excluded
Manufacturer names merged into this page: Zhejiang Longterm Medical Technology Co., LTD · ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD. · ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO. LTD. · ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD · ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO. LTD · Zhejiang Longterm Medical Technology Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000001161
EU authorised representative
Lotus NL B.V.
UK responsible person
lotus global co ltd

Company information

Country
China
City
Deqing Zhejiang
Website
www.longterm-health.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

12019 · K182458
12020 · K192478
12021 · K202823
12022 · K211571

FDA listed device types

showing 8 of 26
Cap, Surgical 1Pad, Eye 1Board, Arm (With Cover), Sterile 1Protector, Ostomy 1Strip, Adhesive, Closure, Skin 1Bedding, Disposable, Medical 1Operating Room Accessories Table Tray 1Dressing, Wound, Occlusive 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06926365597235HekaClass IIb
EU06926365597204HekaClass IIb
EU06926365552807DeciferaClass IIb
EU06926365552838DeciferaClass IIb
UK34864sterile wound dressingClass I
UK16866Medical tapesClass I
UK16866Medical tapesClass I
USK211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit2022-05-31
USK202823Innomed NPWT Silicone Foam Dressing2021-12-15
USK192478LT Antibacterial Alginate with Silver Dressing2020-06-17
BR80691910018Bolsa para Colostomia Uma Peças Transparente - Kangli CareClass II
BR83011600001ColoSenseClass I
BR80937159113Sol Care Filme Transparente em RoloClass II
SAME0000009350SFDAA00022INNOMED OSTOMY BAGS
SAME0000009350SFDAA00024Gentle-Fit ileostomy Bags

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