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Alleva Medical (D.G), Ltd.

China · Dongguan City Guangdong

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Israel — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 7Class II 9Class III 0

plus 41 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered 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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

United States41 registration records, 4 510(k), 0 PMA

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: ALLEVA MEDICAL DEVICES · ALLEVA MEDICAL (D.G.) LTD · ALLEVA MEDICAL LTD · Alleva Medical Ltd.

Same-named companies — This database also contains companies with near-identical names: Alleva Medical, Ltd., ALLEVA MEDICAL DEVICES. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12019 · K191107

22023 · K213906

12025 · K251646

FDA listed device types

showing 8 of 16

Sleeve, Limb, Compressible 1Catheter And Tip, Suction 1Negative Pressure Wound Therapy Powered Suction Pump 1Apparatus, Suction, Patient Care 1Bottle, Collection, Vacuum 1Massager, Powered Inflatable Tube 1Pump, Breast, Powered 1Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251646	extriCARE® 1000 Negative Pressure Wound Therapy System	2025-10-03
US	K213906	extriCARE 1000 Negative Pressure Wound Therapy System	2023-03-08
US	K221223	extriCARE® 3000 Negative Wound Pressure Therapy System	2023-02-09
SA	ME0000003822SFDAA00005	Vide Suction Canister	—
SA	ME0000003822SFDAA00006	Vide Bag Liners	—

Alleva Medical (D.G), Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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