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Sion Biotext Medical Ltd

✓ Record-verifiedregistrations found in 6 marketsEU SRN IL-MF-000012169

This company has registrations in European Union, United States, United Kingdom, Canada, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

65UDI-DI device records

Class I 63Class IIa 2

USUnited StatesFDA openFDA

19listed device types

Class I 12Class II 6Class III 0unclassified 1

plus 38 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 7Class IIa 1

BRBrazilANVISA

0registered devices

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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIa 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 Union65 raw hits, 0 excluded, 65 confirmed

United States38 registration records, 1 510(k), 0 PMA

United Kingdom8 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SION BIOTEXT MEDICAL LTD · Sion Biotext Mexico, S.A.P.I. De C.V., · Sion Biotext Mexico, S.A.P.I. de C.V · SION BIOTEXT MEDICAL LTD.

Regulatory identity

EU manufacturer SRN: IL-MF-000012169
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

FDA 510(k) clearances by year

12015 · K142473

FDA listed device types

showing 8 of 19

Bandage, Cast 1Gauze / Sponge,Nonresorbable For External Use 1Lubricant, Patient 1Gauze/Sponge, Internal, X-Ray Detectable 1Endoscopic Bite Block 1Mirror, Mouth 1Cotton, Roll 1Degreaser, Skin, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	17290108302490	—	Class I
EU	07290108302486	—	Class I
EU	07290108302479	—	Class I
EU	07290108302462	—	Class I
UK	46206	1446 SION (6144)A+D 5GR OINTM	Class I
UK	60796	6*144 LUB JELL 5GR AMAZON	Class IIa
UK	44971	NVP ABSORBENT PAD 20X40 STERILE. SINGLE PACK.	Class I
US	K142473	Lubricating Jelly	2015-04-13
CA	83071	STERILE LUBRICATING JELLY	Class II

Sion Biotext Medical Ltd

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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