Home›Germany›SCHEBO BIOTECH AG

SCHEBO BIOTECH AG

Germany · Giessen

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Israel, Russia — 8 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

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 3Class II 0Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 2Class 2a 1

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.

United States3 registration records, 0 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: SCHEBO BIOTECH AG

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80213250747	ScheBo® Pancreas Elastase 1 Quick stool test	Class II
BR	80213250748	ScheBo® Master Quick-Prep	Class I
BR	80213250749	ScheBo® Pancreatic Elastase 1 Serum Test	Class II
CA	39231	SCHEBO PANCREATIC ELASTASE 1 STOOL TEST	Class II
CA	89875	SCHEBO PANCREATIC ELASTASE 1	Class II
CA	90483	SCHEBO . M2-PK QUICK	Class II

SCHEBO BIOTECH AG

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies