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Chirurgische Instrumente

Germany · Balgheim

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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

73listed device types

Class I 68Class II 5Class III 0

plus 79 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 14

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.

United States79 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: HAFNER CHIRURGISCHE INSTRUMENTE · H.+H. Maslanka Chirurgische Instrumente GmbH · VINZENZ SATTLER chirurgische Instrumente GMBH · WEINMANN GMBH CHIRURGISCHE INSTRUMENTE · H.+ H. MASLANKA CHIRURGISCHE INSTRUMENTE GMBH · H. + H. MASLANKA CHIRURGISCHE INSTRUMENTE GMBH

FDA 510(k) clearances by year

11992 · K922299

41995 · K944444

FDA listed device types

showing 8 of 73

Instrument, Ent Manual Surgical 1Elevator 1Hook, Bone 1Probe 1Chisel, Surgical, Manual 1Rasp 1Forceps 1Accessories, Cleaning Brushes, For Endoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K944444	CIT BIOPSY PUNCHES	1995-09-29
US	K944270	CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS	1995-07-25
US	K944268	CIT TWO WAY SUCTIN AND IRRIGATION TUBES	1995-01-26
BR	80884749006	Aplicadores UniTip	Class II

Chirurgische Instrumente

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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