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Biotech GmbH

Germany · Rheinbrohl · www.biotech-medical.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, Canada — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 1Class IIb 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

0active device licences

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 Union52,774 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States1 registration records, 2 510(k), 0 PMA, 233 excluded

United Kingdom2 confirmed, 127 excluded

Brazil0 confirmed, 140 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 41 excluded

Manufacturer names merged into this page: BIOTECH, INC.

Regulatory identity

UK responsible person: Regen Marketing Limited

Market	Identifier	Name	Class / date
UK	61522	Biotech Pectus Instrument Set	Class IIb
UK	47446	Cryolock Family Devices	Class IIa
US	K192294	I Do	2020-07-31
US	K122982	CRYOLOCK	2014-01-09

Biotech GmbH

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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