HomeGermanyRUDOLF MEDICAL GMBH + CO. KG

RUDOLF MEDICAL GMBH + CO. KG

Germany · Fridingen
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, 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
pendingnot queried
USUnited StatesFDA openFDA
93listed device types
Class I 82Class II 11Class III 0
plus 91 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 4Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
70registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
15active device licences
Class II 15
45 including historic records
TWTaiwanTFDA
8valid device licences
Class I 5Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
55active ARTG entries
Class I 40IIa 11IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
16active registrations
Class 2a 16
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 States91 registration records, 1 510(k), 0 PMA, 5 excluded
Brazil5 confirmed, 2 excluded
Saudi Arabia70 confirmed, 1 excluded
Canada15 confirmed, 1 excluded
Manufacturer names merged into this page: RUDOLF MEDICAL GMBH + CO. KG · RUDOLF MEDICAL GMBH & CO KG · RUDOLF MEDICAL GMBH & CO. KG · RUDOLF MEDICAL GmbH + Co. KG

Company information

Country
Germany
City
Fridingen

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12008 · K073498

FDA listed device types

showing 8 of 93
Chisel, Surgical, Manual 1Gag, Mouth 1Fork, Tuning 1Orthopedic Manual Surgical Instrument 1Knife, Ear 1Syringe, Irrigating (Non Dental) 1Catheter, Cholangiography 1Instrument, Manual, General Obstetric-Gynecologic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK073498LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM2008-09-19
BR80091010015INSTRUMENTAIS CORTANTES ARTICULADOS RUDOLFClass I
BR80091010016INSTRUMENTAIS CORTANTES NÃO ARTICULADOS RUDOLFClass I
BR80091010017INSTRUMENTAIS NÃO CORTANTES NÃO ARTICULADOS RUDOLFClass I
SAME0000011012SFDAA00008RUDOLF Medical Needle Holder
SAME0000011012SFDAA00006RUDOLF Light Source
CA101418PROCTOSCOPEClass II
CA102018FINGER NAIL DRILLClass II
CA102493DILATORS, VASCULARClass II

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