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STEMA Medizintechnik GmbH

Germany · Neuhausen · www.stema-medizintechnik.de

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, 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

0UDI-DI device records

USUnited StatesFDA openFDA

11listed device types

Class I 11Class II 0Class III 0

plus 11 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

40registered device records

Class I 25Class IIa 10Class IIb 5

BRBrazilANVISA

20registered devices

Class I 11Class II 9

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

9registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 4IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 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.

European Union7,540 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States11 registration records, 0 510(k), 0 PMA

United Kingdom40 confirmed, 0 excluded

Brazil20 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Manufacturer names merged into this page: STEMA MEDIZINTECHNIK GMBH · STEMA MEDIZINTECHNIK GMBH. H.-E · STEMA Medizintechnik GmbH

Regulatory identity

UK responsible person: Compliance Solutions (Lifesciences) Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
UK	37143	Ellik evacuator, complete	Class I
UK	47487	Adapter for 2-pin plug	Class I
UK	37086	Applicator used for the Mini-nephroscope sheaths	Class IIa
BR	81271570012	Endoscopio stema medizintechnik gmbh	Class II
BR	10303320071	INSTRUMENTOS CIRÚGICOS ARTICULADOS CORTANTES STEMA	Class I
BR	81271570019	INSTRUMENTAL STEMA MEDIZINTECHNIK GMBH 3	Class I
SA	ME0000000889SFDAA00006	Biopsy Forceps	—
SA	ME0000003495SFDAA00220	Hook Scissors	—

STEMA Medizintechnik GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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