HomeGermanyKessel medintim GmbH

Kessel medintim GmbH

Germany · Mörfelden-Walldorf · www.medintim.de
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Australia, Israel — 7 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
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
13registered device records
Class I 8Class IIa 2Class IIb 2System or Procedure Pack 1
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 4IIa 1IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
10registrations
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 States4 registration records, 1 510(k), 0 PMA
United Kingdom13 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: KESSEL MEDINTIM GMBH · Kessel Medintim GmbH

Regulatory identity

UK responsible person
Psephos Limited

Company information

Country
Germany
Website
www.medintim.de
Product categories
Clinical Diagnostics & Therapeutic TechnologiesWomen’s Health, Neonatology & Pediatric CareFertility & contraception technologies

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

12014 · K140305

FDA listed device types

Clamp, Penile 1Dilator, Cervical, Fixed Size 1Device, External Penile Rigidity 1Diaphragm, Contraceptive (And Accessories) 1

Registration details (sample)

MarketIdentifierNameClass / date
UK42405Caya contoured diaphragmClass IIb
UK46334Constriction Rings / Pubic Rings 12mmClass I
UK17744Manual Erection SystemClass I
USK140305CAYA CONTOURED DIAPHRAGM2014-08-26
SAME0000005060SFDAA00005Vagiwell Dilators
SAME0000005060SFDAA00004Constriction rings

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