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STIHLER ELECTRONIC GMBH

Germany · Leinfelden-Echterdingen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 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

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 4Class III 0

plus 8 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

5 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 2IIb 4

HKHong KongMDACS

4valid listings

Class II 1Class III 3

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 6

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 States8 registration records, 8 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: STIHLER ELECTRONIC GMBH

FDA 510(k) clearances by year

11988 · K882361

21999 · K991159

12002 · K020103

22008 · K082758

12020 · K202197

12026 · K260278

FDA listed device types

Warmer, Thermal, Infusion Fluid 1Warmer, Blood, Non-Electromagnetic Radiation 1System, Thermal Regulating 1Accessories, Blood Circuit, Hemodialysis 1Surgical Table Cushion 1Transilluminator, Battery-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260278	ThermAffyx(TM) Patient Safety System	2026-07-08
US	K202197	Astopad Patient Warming System	2020-09-04
US	K082758	PRISMAFLO II	2008-12-19
BR	80271299011	EQUIPAMENTO PARA TERMOTERAPIA ASTOPAD STIHLER	Class II
BR	80271299012	AQUECEDOR DE FLUIDOS STIHLER	Class II
BR	80271299008	AQUECEDOR ASTOPAD STIHLER	Class II

STIHLER ELECTRONIC GMBH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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