GaleMed

✓ Record-verifiedregistrations found in 10 marketsEU SRN TW-MF-000022411Unified social credit code 913502057980788692

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, South Korea, Australia, Israel — 9 overseas markets. EU UDI-DI records ≥210, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

2China registrations

Class I 2

as of 2026-09-04

EUEuropean UnionEUDAMED

≥210UDI-DI device records

Class I 2Class IIa 208

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

33listed device types

Class I 18Class II 15Class III 0

plus 44 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

50registered device records

Class I 4Class IIa 46

BRBrazilANVISA

3registered devices

Class II 3

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

9active device licences

Class II 9

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 4

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.

European Union1,791 raw hits, 90 excluded, 210 confirmed. Large result set — only the first 300 verified

United States44 registration records, 7 510(k), 0 PMA, 2 excluded

China2 certificates (Class III 0 / II 0 / I 2), as of 2026-09-04

United Kingdom50 confirmed, 1 excluded

Brazil3 confirmed, 1 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: GALEMED CORP. · GALEMED CORPORATION

Regulatory identity

EU manufacturer SRN: TW-MF-000022411
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited
Unified social credit code: 913502057980788692
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2007-06-04
Registered capital: CNY 3,022,299
Paid-in capital: CNY 3,022,299
Legal form: Limited liability company (wholly owned by a foreign-invested enterprise)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-07-07
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12002 · K021742

12003 · K022124

12007 · K072755

12008 · K082092

12013 · K122627

22014 · K132679

FDA listed device types

showing 8 of 33

Display, Cathode-Ray Tube, Medical 1Filter, Bacterial, Breathing-Circuit 1Spirometer, Monitoring (W/Wo Alarm) 1Ventilator, Non-Continuous (Respirator) 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Meter, Peak Flow, Spirometry 1Attachment, Breathing, Positive End Expiratory Pressure 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	闽厦械备20240577	医用吸氧面罩	Class I
CN	闽厦械备20240335	鼻氧管	Class I
EU	04710810083297	Silicone Flex Tube, 13cm, 22F, 15F	Class IIa
EU	04710810107788	L Connector, 22F, 22/15mm PSF	Class IIa
EU	04710810084515	L Connector, 22F, 22/15mm, PSF	Class IIa
EU	04710810118166	Connector, 10/7.6mm, 10f, PSF	Class IIa
UK	37021	Scavenging Bag 3L, Reusable	Class IIa
UK	37021	Sil.Flex Catheter Mount, 15F, 15M, PC	Class IIa
UK	37021	Silicone Circuit, Adult, 120cm	Class IIa
US	K132679	AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER	2014-04-18
US	K133957	DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE	2014-04-14
US	K122627	GIO DIGITAL PRESSURE GUAGES	2013-08-22
BR	80301139039	Valvula de PEEP	Class II
BR	80301139034	R7 Ressuscitador Manual Infantil	Class II
BR	80301139035	Venti Plus	Class II
CA	65684	MANUAL RESUSCITATOR SETS (REUSABLE)	Class II
CA	65698	CONNECTORS	Class II
CA	65699	ORAL AIRWAY	Class II