Wellell

✓ Record-verifiedregistrations found in 7 marketsEU SRN TW-MF-000009159Unified social credit code 110000000000000000

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia — 7 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

148UDI-DI device records

Class I 35Class IIa 113

USUnited StatesFDA openFDA

7listed device types

Class I 1Class II 6Class III 0

plus 13 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class I 6Class IIa 7

BRBrazilANVISA

4registered devices

Class II 4

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

17active device licences

Class II 17

19 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 4IIa 1

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 Union150 raw hits, 2 excluded, 148 confirmed

United States13 registration records, 2 510(k), 0 PMA

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom13 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: Wellell Inc. · WELLELL INC.

Regulatory identity

EU manufacturer SRN: TW-MF-000009159
EU authorised representative: Wellell Iberia S.L.
UK responsible person: Wellell UK Limited
Unified social credit code: 110000000000000000
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai)

FDA 510(k) clearances by year

22025 · K251466

FDA listed device types

Sleeve, Limb, Compressible 1Ventilator, Non-Continuous (Respirator) 1Nebulizer (Direct Patient Interface) 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Mattress, Air Flotation, Alternating Pressure 1Bed, Flotation Therapy, Powered 1Cushion, Flotation 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719893357233	—	Class I
EU	04719893357219	CR100	Class I
EU	04719893348897	Flexi-Air	Class I
EU	04719893348859	—	Class I
UK	47478	Domus 1	Class IIa
UK	63241	Domus ECO	Class I
UK	63241	CR100	Class I
US	K251466	VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr	2025-10-28
US	K243023	WiZARD 520 Full Face Mask	2025-05-23
BR	10349590117	Máscara Facial Wellell	Class II
BR	10349590118	Máscara Nasal Wellell	Class II
BR	10349590083	UMIDIFICADOR AQUECIDO XT	Class II
CA	758	ELECTROTHERAPY UNITS	Class II
CA	62287	APM 480 ALTERNATING LOW PRESSURE PUMP AND MATTRESS SYSTEM	Class II
CA	62555	NEO SERIES ALTERNATING PRESSURE SUPPORT SURFACES	Class II

Wellell

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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