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Bio Compression Systems Inc.

USA · Moonachie NJ · www.biocompression.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN US-MF-000008442

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 9 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

115UDI-DI device records

Class I 108Class IIa 7

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 14 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 5

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

3active device licences

Class II 3

9 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 Union116 raw hits, 1 excluded, 115 confirmed

United States14 registration records, 15 510(k), 0 PMA, 12 excluded

United Kingdom5 confirmed, 1 excluded

Brazil4 confirmed, 1 excluded

Canada3 confirmed, 2 excluded

Manufacturer names merged into this page: BIO COMPRESSION SYSTEMS, INC.

Regulatory identity

EU manufacturer SRN: US-MF-000008442
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00812311023056	VascuEase	Class I
EU	00812311023032	Elite 8 Vest	Class I
EU	00812311021526	Elite 8 Vest	Class I
EU	00812311023025	Elite 8 Vest	Class I
UK	44768	Arterial Arm Sleeve	Class I
UK	37240	BioCryo Gel Insert - Large	Class I
UK	37240	Cryo Ankle	Class I
US	K250974	Bio Arterial Deluxe (IC-BAP-DX)	2025-12-12
US	K213533	Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL	2022-02-16
US	K210417	Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL	2021-05-14
BR	10103579003	SISTEMA DE BIOCOMPRESSÃO VASCUEASE	Class II
BR	81231559066	Sistema de Biocompressão VascuEase	Class II
BR	10103570019	Sistema de Compressão de Membros	Class II
CA	81407	BIOCOMPRESSION SYSTEMS	Class II
CA	81408	COMPRESSION GARMENTS	Class II
CA	81409	MULTI FLO DVT	Class II

Bio Compression Systems Inc.

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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