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ENTER MEDICAL CORPORATION

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

21listed device types

Class I 18Class II 3Class III 0

plus 21 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class II 1

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 Union28,079 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States21 registration records, 1 510(k), 0 PMA

United Kingdom0 confirmed, 50 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: ENTER MEDICAL CORPORATION

Regulatory identity

Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12005 · K042556

FDA listed device types

showing 8 of 21

Strap, Head, Gas Mask 1Tube, Laryngectomy 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Endoscopic Bite Block 1Laryngoscope, Rigid 1Clip, Lens, Trial, Ophthalmic 1Screw, Oral 1Set, Tubing And Support, Ventilator (W Harness) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K042556	SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,	2005-03-11
BR	80488290005	EXTENSÃO DE OXIGÊNIO LUMIAR	Class II

ENTER MEDICAL CORPORATION

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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